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CIZZLE BIOTECHNOLOGY HOLDINGS PLC

Annual Report Jul 8, 2025

4889_10-k_2025-07-08_d210a193-b519-40f4-a57c-ba2b67691bd8.pdf

Annual Report

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Annual Report for the year ended 31 December 2024

Company registered number: 06133765

Annual Report for the year ended 31 December 2024

Contents

Page

Company Information

Directors

Allan Syms Nigel Lee Prof. Dawn Coverley John Treacy Matt Bower

Company Secretary

SGH Company Secretaries Limited

Registered Number Registered Office

06133765 6

Executive Chair Finance Director Chief Scientific Officer Non- Executive Non-Executive

th floor, 60 Gracechurch Street London, EC3V 0HR

Financial Public Relations

IFC Advisory Limited Birchin Court, 20 Birchin Lane London EC3V 9DU

Broker and Financial Adviser

Allenby Capital Limited 5 St. Helen's Place London, EC3A 6AB

Solicitors

London Birmingham EC2N 4BQ B4 6AA

Independent Auditor

PKF Littlejohn LLP Statutory Auditor 15 Westferry Circus London E14 4HD

Registrar

Neville Registrars Limited Neville House Steelpark Road Halesowen B62 8HD

Bankers

National Westminster Bank PLC, 27, Market Place, Romsey, SO51 8ZH

Cooley (UK) LLP Shakespeare Martineau 22 Bishopsgate No 1 Colmore Square

Chair's Statement

The Group continued throughout 2024 to develop a blood test to measure the CIZ1B cancer biomarker. CIZ1B is a variant of CIZ1, a naturally occurring cell nuclear protein involved in protecting DNA, and the targeted CIZ1B variant has been shown to be highly correlated with early-stage lung cancer.

Based on the original published research by Professor Coverley and her team at the University of York, it has been shown that CIZ1B can be measured with high sensitivity, and that it can report on the presence of lung cancer in a high-throughput, hospital-friendly blood test format. The Directors believe that this development addresses an important unmet clinical need for a simple scalable test that can help with the detection of lung cancer in its early stages, which is essential to improve a patient's chance of survival.

The Group's initial commercial product for a non-invasive, cost effective and simple blood test will be based on an immunoassay platform that can be readily performed by hospitals and reference laboratories. Shareholder value will be created through a global commercial strategy of developing corporate partnerships generating royalty-bearing licence fees, sales of proprietary antibodies and molecular tools to support the blood test, plus equity participation in partners where possible. In a highly regulated market appropriate for clinical diagnostics, and to ensure the earliest availability to patients, the group has adopted a first to market approach by working with accredited laboratories that perform assays as laboratory developed tests ("LDT").

The Group is now well positioned to advance its vision to help make a global shift in lung cancer survival through accurate, low cost, non-invasive early detection at scale and to deliver its mission to transform lung cancer survival, by empowering healthcare professionals and patients to enable curative medical intervention using a groundbreaking and affordable diagnostic blood test that can detect lung cancer early.

Product Development, Clinical Evaluation and Future Research

Throughout 2024, the Group continued to work with external expert partners and suppliers and in July entered into a strategic agreement with BBI Solutions ("BBI"), the world's largest independent producer of immunodiagnostic reagents, to supply its first order of commercial propriety monoclonal antibodies – which are required and provide a unique means to measure the level of CIZ1B in blood samples. The initial order was manufactured at their ISO 13485-certified facilities and is expected to support up to 5,000 assays. Supplies have now been validated and distributed to our US partners, and are crucial for advancing the clinical evaluation process and in meeting a key milestone in bringing the test to market.

The continuing agreement with the University of York and extended access to state-of-the-art facilities and world leading scientists has again achieved important technical and product milestones including the production of molecular tools, development and quality assessment of monoclonal antibodies, clinical evaluation studies and in optimising the standard operating procedure ("SOP") which together with our commercial grade monoclonal antibodies provides the basis for rolling out of a scalable, non-invasive, cost effective immunoassay for CIZ1B biomarker testing for early lung cancer.

In terms of future research, the team at the University of York under the leadership of the Group's Chief Scientific Officer, Professor Dawn Coverley will be evaluating how the Group's CIZ1B biomarker may be used in point of care devices, and for other types of cancer.

In September 2024, the Group announced it had been selected by the Moffitt Cancer Center ("Moffitt"), the number one cancer hospital in Florida and the Southeast USA, to test patients with suspicious lung nodules in a clinical evaluation using the Company's proprietary CIZ1B biomarker assay.

With multiple sites and over 7,000 employees, Moffitt is the only US National Cancer Institute-designated 'Comprehensive Cancer Center' based in Florida. They have developed a comprehensive lung cancer screening programme that is among the best in the United States, which has resulted in them being named a Screening Center of Excellence by the GO2 Foundation for Lung Cancer.

Moffitt's Phase 2 programme, "Using Biomarkers for Diagnosis, Risk Stratification of Post-treatment Recurrence and Long Term Survival of Lung Cancer", is a large observational prospective study in patients with suspicious indeterminate (undiagnosed) lung nodules found in the Lung Cancer Early

Chair's Statement continued

Detection (LEAD) Center Lung Nodule Clinic, directed by Dr. Lary Robinson. As part of this study the Company will for the first time be analyzing unknown patient blood samples to determine biomarker accuracy in predicting whether or not a nodule is likely to be cancer. The blood sample tests for CIZ1B will be conducted in Professor Dawn Coverley's laboratory at the University of York. The study follows US nationally recommended guidelines and will be using the first batch of the Company's new commercial monoclonal antibody, to provide new sensitivity and specificity data for the CIZ1B biomarker blood test. It will provide blinded clinical real-world data about the tests value in the diagnostic process, for people with indeterminant lung nodules that might be cancer. Future studies will evaluate the CIZ1B biomarker blood test in other clinical contexts.

Global Market Access through Building Strong Partnerships

The Group has continued to develop its collaborations with existing partners in the USA and China as part of its global licensing strategy to deliver shareholder value through royalty payments and potential benefits arising from equity participation in the partner companies where possible.

On 21 October 2024 the Group announced an exclusive licensing and partnership agreement with Cizzle BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA and Canada. The Group has since received payments of US\$400,000 due from initial exclusivity fees and advanced royalties as part of guaranteed payments totalling US\$2.4 million over the period ending April 2027. In addition, the Group will benefit from its equity participation in Cizzle BIO.

The Group has now extended that agreement, as announced on 16 December 2024, to cover the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") triggering early payments totalling US\$250,000 in July 2025 and US\$250,000 in September 2025 of the advanced minimum royalty of US\$1 million previously all due on 21 January 2026. As announced by the Company on 28 April 2025 BIO has executed its first Laboratory Services Agreement with Doctors Hospital (Chrissie Tomlinson Memorial Hospital (CTMH) in the Cayman Islands.

On 24 March 2025, the Group announced that its licensing partner Cizzle Bio had appointed iGenomeDX, a specialist clinical diagnostics laboratory to launch the Group's first commercial CIZ1B biomarker test in the USA. iGenomeDX is a Commission on Office Laboratory Accreditation ("COLA") accredited and Clinical Laboratory Improvement Amendments ("CLIA") certified clinical laboratory and has been establishing operating and quality systems ahead of offering the test to clinicians for the first time.

The appointment of iGenomeDX by BIO, is an important step in the Group's plan to achieve commercial sales by providing an accredited facility to launch the CIZ1B biomarker test. The accreditation process involved an evaluation of a laboratory's operations, including its testing procedures, quality control, personnel qualifications, and compliance with regulatory requirements. Labs that achieve COLA accreditation demonstrate a commitment to maintaining high standards of accuracy, reliability, and patient safety in diagnostic testing to ensure they meet CLIA standards and can legally operate. Cizzle Bio intends to complete CLIA accreditation shortly and then secure first commercial sales immediately thereafter.

The appointment of these initial clinical laboratories is the start of BIO's strategy to build a network across the USA and its accreditation and launch plans are being synchronised to enable a co-ordinated and comprehensive campaign to roll out the CIZ1B biomarker test to help detect early-stage lung cancer.

The successful completion of the operational and quality systems programme, that demonstrates rigorous quality control and reproducibility and sensitivity standards, is necessary for launching a cost-effective and scalable version of the CIZ1B biomarker assay. This will validate that the test is commercially scalable and can be rolled out as a global solution to help reduce premature cancer deaths and improve survival rates and quality of life for cancer patients.

Strengthening the Board and Leadership Team

Professor Dawn Coverley (Chief Scientific Officer, "CSO")

On 1 Jan 2025, to directly support and accelerate the Company's global licensing and partnership strategy to bring its non-invasive, cost effective, CIZ1B biomarker lung cancer blood test to market in 2025, Professor Dawn Coverley, Founder and Non-Executive Director ("NED") of Cizzle Biotechnology was appointed Chief Scientific Officer ("CSO"), an executive role on the board of the Company.

Chair's Statement continued

The change in role from NED to CSO, enables Dawn to allocate more of her expert time to directly support the Company's licensing partners, particularly in the USA, to accredited laboratory partners, helping them to achieve CLIA (Clinical Laboratory Improvement Amendments) LDT (Laboratory Developed Test) accreditation and identify and lead new non-dilutive grant funded research and clinical evaluations.

Dawn is currently a professor and principal investigator of a research laboratory at the University of York, studying how specialised cells are protected from age-related decay. After a first degree in Genetics (Leicester), and a PhD in Biochemistry (Cancer Research UK), she completed postdoctoral training at the

University of Cambridge, then moved to the University of York to establish an independent research group in 2002, supported by the Lister Institute of Preventive Medicine.

Dawn will reduce a number of her current teaching and scientific roles at the University of York in order to devote sufficient time to the Company's activities, whilst maintaining a number of key roles, including leadership of her research group and management of the Company's existing research and development contract at the University of York.

The timing of this appointment coincides with the successful completion of the technical programme which confirms that the most cost-effective and scalable version of the CIZ1B biomarker assay for CLIA accreditation is an ELISA. The rigorous quality control programme undertaken has been able to demonstrate equivalence with initial manual laboratory tests and with the BioTechne ProteinSimple capillary Western system. Results have shown sensitivity equivalent to published CIZ1B lung cancer studies *, and an ability to correctly identify people with lung cancer with few false negative results. This is another major step in demonstrating that the Company's lung cancer blood test is both cost effective and a commercially scalable global solution that could reduce premature cancer deaths and improve survival rates and quality of life for cancer patients.

Matthew Bower (Non-Executive Director, "NED")

Matt Bower is an experienced company executive and adviser with a track record as a director and secretary of private equity backed and listed companies, across a broad range of company and technology related activities, was appointed as a Non-Executive Director of the Board on 21 March 2025. He is engaged as a strategic advisor and mentor to the board of directors of a number of high growth trading and technology companies, and a director of a number of private companies.

Matt will sit on both the Company's audit and remuneration committees, alongside the Company's independent Non-Executive Director, John Treacy, replacing Prof Dawn Coverley who recently moved from her role as a NED to Chief Scientific Officer, as announced on 2 January 2025.

Matt is a Director of Makabo Limited ("Makabo"), a strategic consultancy and board advisory business. On the 24 June 2024, the Company entered into an agreement (the "Agreement") with Makabo to support the Board in the areas of strategy, partnerships, licensing and shareholder communications. With Matt joining the Board, the Agreement has now been terminated. Pursuant to the Agreement, Makabo waived payment of more than 85 per cent of its contracted fees to link remuneration directly to the success of the Company, by accepting 2,464,625 options over new Ordinary Shares (the "Options") with an exercise price of 1.622965p per ordinary share. The Options were granted on a pro-rata monthly basis and will all vest and become exercisable on 25 June 2025 assuming that the VWAP of the Ordinary Shares for the period 25 May 2025 to 24 June 2025 is equal or greater than 3.24593p, being twice or greater than the Options grant price. The Options remain exercisable until 25 June 2027.

Funding

On 26 March 2024 the Group announced that it had undertaken a conditional placing of 31,050,000 new ordinary shares of 0.01p each ("Ordinary Shares") in the Company (the "Placing") at a price of 2 pence per share (the "Issue Price") raising approximately £0.62 million before expenses for the Group. The net proceeds of the Placing are being utilised towards completing the Group's first proposed commercial test to detect CIZ1B, further protect the Group's Intellectual Property (IP), progress the Group's research with the University of York and for general corporate purposes.

At the same time, upon completion of the Placing, the Group terminated the £500,000 loan facility agreement with E3 Fund SP entered into on 20 September 2022. This facility had not been drawn down.

Chair's Statement continued

The Group also agreed to issue 1,500,000 new Ordinary Shares at 2p per new Ordinary Share in satisfaction of a payment of £30,000 for professional advisory services to Novum Securities Limited.

Financial overview

The financial results for the year ended 31 December 2024 are summarized below:

  • Corporate expenses, before share option charge and exceptional items: £687,000 (2023: £669,000) - Share option charge: £189,000 (2023: £307,000);
  • Exceptional corporate expenses relating to net measurement losses on the current asset investment and the transfer of intangible asset: £1,391,000 (2023: £831,000);
  • Total comprehensive loss: £2,166,000 (2023: Loss £1,717,000); and
  • Loss per share 0.6 (2023: Loss 0.5p).

The Group has now met its major research and development milestones, required to launch its first commercial product. The appointment of iGenomeDX by Cizzle BIO, to achieve CLIA accreditation and securing its first hospital contract in the Caribbean enables provides a base for the first paid for clinical test for the CIZ1B biomarker which will be a pivotal moment. The Group is now entering a new business growth phase, securing further licensing partners, generating licensing revenue and bringing this important innovation to benefit of patients through early lung cancer diagnosis and enabling curative intervention.

Allan Syms Executive Chair 30 April 2025

Board of directors

Dr Allan Syms (Executive Chair), appointed 21 May 2019

Allan is an experienced international life sciences and technology senior executive, with over 30 years of experience at Board level often as founder or chief executive officer in creating, funding and building emerging technology businesses through to trade sale and IPO. After gaining a PhD in cancer biology at the Tenovus Institute of Cancer Research and postdoctoral fellowships at Baylor College of Medicine in Houston and Oxford University, he began his corporate career at GE Healthcare (formerly Amersham International PLC) to develop novel diagnostic detection systems. He then worked with a number of UK leading universities to spin out and develop technology businesses. Allan has extensive experience in M&A, licensing and managing strategic change, becoming corporate marketing director at Integra Biosciences AG a leading Swiss laboratory and diagnostics supplies company. He was previously a specialist adviser on China to the Department of International Trade.

Allan was appointed Non-Executive Chair on 21 May 2019 and was appointed Executive Chair with effect from 14 May 2021.

John Treacy (Non-Executive Director), appointed 29 January 2019

John is a London-based experienced financier who specialises in working with growing companies. He qualified as a solicitor in the London office of a major international law firm where he specialised in Capital Markets and Mergers & Acquisitions. From there he moved to practice corporate finance in the advisory teams of several prominent UK brokerages where he acted as an adviser to a number of AIM companies and advised on numerous IPOs, acquisitions, debt restructurings and placings.

John is also the Chair of the Audit and Risk Committee and the Chair of the Remuneration Committee.

Professor Dawn Coverley (Chief Scientific Officer), appointed 14 May 2021

Dawn is a cell biologist with over 20 years' experience in cancer-related research. After a first degree in Genetics (Leicester), and a PhD in biochemistry (Cancer Research UK), she completed postdoctoral training at the University of Cambridge, then moved to the University of York to establish an independent research group in 2002, supported by the Lister Institute of Preventive Medicine. Her research exploits experimental systems that reconstitute fundamental processes associated with genome and epigenome stability, and their contribution to the earliest stages of human cancers. She founded Cizzle Biotechnology Limited and raised early-stage funding in 2006 to begin development of her research findings into clinically useful products, focused on CIZ1B and the early detection of lung cancer. She is currently principal investigator of an academic research laboratory at the University of York and Scientific Director of Cizzle Biotechnology.

Dawn was a member of the Audit and Risk Committee and Remuneration Committee until her appointment as an executive director on 1 January 2025.

Nigel Lee (Finance Director), appointed 14 May 2021

Nigel has been a director of CFO Solutions Limited since 2003 which has provided financial advisory services to the Group since 2010, as well as company secretarial services since 2012. CFO Solutions Limited ceased providing these services to the Group on 14 May 2021. He is also a part-time Finance Director of Kent Surrey Sussex AHSN Limited. He was financial director/controller in two IT services and software companies between 1999 to 2003 and prior to that had 11 years of audit and business advisory experience at PricewaterhouseCoopers. Nigel qualified as a Chartered Accountant in 1988.

Matt Bower (Non- Executive Director), appointed 21 March 2025

Matt is a highly experienced executive, director, and company secretary with extensive experience in private equity-backed and publicly listed companies. He specialises in delivering transactional and commercial strategies that drive growth and value. As a strategic advisor and mentor, Matt brings expertise in operational, financial, and risk management to support high-growth businesses across innovation, technology, and trading sectors. A Class 1 Master Mariner, he earned his qualification from Solent University, Southampton.

Matt will sit on both the Company's audit and remuneration committees, alongside the Company's independent Non-Executive Director, John Treacy, replacing Prof Dawn Coverley who recently moved from her role as a NED to Chief Scientific Officer, as announced on 2 January 2025.

Strategic Report for the year ended 31 December 2024

The directors present their strategic report for the year ended 31 December 2024.

Business review

The review of the Group is detailed in the Chair's Statement on pages 2 to 5.

Principal risks and uncertainties

The principal risks and uncertainties of the Group are as follows:

Early-stage revenue business

The Group is still at an early stage of its development cycle, has not received some initial royalty revenues from Bio which it expects to account as income in the Statement of Comprehensive Income in 2025. The generation of revenues can be difficult to predict and although there is no guarantee that the Group will generate significant revenues in the foreseeable future, revenue is expected in 2025. There are a number of operational, strategic and financial risks associated with early-stage companies. The Group will face risks frequently encountered by pre-revenue companies looking to bring new medical devices to the market. For the foreseeable future, the Group will have significant reliance upon the success of the CIZ1B biomarker in the detection of lung cancer. There is no guarantee that the Group's intellectual property will ultimately protect a commercially viable test for the detection of lung cancer. It is also possible that technical and/or regulatory hurdles could lengthen the time required for the delivery of such a testing product.

The Group's prospects, inter alia, rest initially upon the rate of consumer penetration for its test for the early detection of lung cancer. The Group's future growth and prospects will also depend on its ability to secure further commercialisation partnerships on appropriate terms, to manage growth and to expand and improve operational, financial and management information, quality control systems and its commercialisation function on a timely basis, whilst at the same time maintaining effective cost controls. Any failure to expand and improve operational, financial and management information and quality control systems in line with the Group's growth could have a material adverse effect on the Group's business, financial condition and results of operations.

Regulatory environment and the process for obtaining regulatory clearance

The Group's prospective future products will be subject to various laws, regulations and standards in each of the jurisdictions in which products are to be manufactured and distributed. The Board intends to launch its first commercial product in the USA, with commercial grade antibody, and operating protocols for the CIZ1B biomarker test to be delivered through its partnership with Cizzle Bio Inc as a Laboratory Developed Test (LDT).

Verifying Accurate Leading-edge IVCT Development (VALID) Act

On 29 September 2023, the Food and Drug Administration (FDA) announced the publication of a proposed rule to "clarify" that LDTs are medical devices subject to FDA regulation. LDTs are diagnostic tests that are developed and offered by high-complexity laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). While FDA has asserted that it has authority to regulate LDTs as medical devices, it has never broadly exercised that authority. In the proposed rule, FDA seeks to amend its regulation defining "in vitro diagnostic products" (IVDs) to add the words "including when the manufacturer of these products is a laboratory" which would mean LDTs would be treated as medical devices and require FDA approval. Currently the VALID Act bill has not been enacted to enable Congress to work with key stakeholders on legislative proposals for regulating diagnostics, including LDTs especially those within the laboratory community and others have long taken the position that FDA does not have authority under the FDCA to regulate LDTs.

On 1 April 2025 U.S. District Court Judge Sean D. Jordon has ruled that the U.S. Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests (LDTs), finding squarely in favour of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs. The court stated that the "proper remedy is vacatur of the final rule" and remanded the case to the FDA for further consideration in light of the opinion.

Strategic Report for the year ended 31 December 2024

Principal risks and uncertainties (continued)

Regulatory environment and the process for obtaining regulatory clearance (continued)

Judge Jordon's order to vacate the rule means that the Final Rule issued by FDA is no longer legally binding. As a result, clinical laboratories with LDTs are not required to comply with FDA's implementation requirements for LDT oversight. It is unclear whether the Trump Administration will seek to appeal the ruling. However, ASCP has urged the Trump Administration to rescind the rule and will urge the Administration not to appeal the ruling.

Globally, the use of LDTs or in House Developed Tests vary from country to country. In Europe, to be exempted from most of the provisions of Regulations (EU) 2017/745 (medical devices Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR), provided the health institution adheres to the conditions laid out in Article 5(5) of the relevant Regulation. Laboratories have to be considered as a health institution and be accredited to ISO 15189.

The Group's future products are likely to require UKCA, CE Marking, or FDA 510(k) clearance, There can be no guarantee that the Group's products will obtain UKCA, CE marking, LDT or FDA 510(k) clearance, or that they can be obtained within the timescales or the budgets anticipated by the Directors.

The Group intends to pursue UKCA, CE marking approval, LDT accreditation or FDA 510(k) clearance via the use of retrospective testing data. However, if retrospective testing data is not sufficient to obtain UKCA, CE marking approval, LDT accreditation and/or FDA 510(k) clearance, then the Group may need to complete a prospective study, which it is anticipated would be more expensive and would take longer.

Any other potential delays in obtaining the UKCA CE marking approval, LDT accreditation or potentially FDA 510(k) clearance would adversely affect the timing of the Group's future product sales into the EU (or the USA in the case of a LDT or FDA 510(k) clearance). There is no guarantee that there will not be an extended period of requests for information or supporting data that could add to the timing for receiving the UKCA/CE mark (or potentially a LDT or FDA 510(k) clearance).

There remain significant uncertainties associated with the exit by the UK from its membership of the European Union. Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). On 9 January 2024, the MHRA released a Roadmap towards the future regulatory framework for medical devices. This provides an update on the intended timelines to implement the future core regulations.

UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the "CE UKNI" marking, which is valid in Northern Ireland) – and have become UK Approved Bodies.

a new route to market and product marking is available for manufacturers wishing to place a device on the Great Britain market;

since 1 January 2021, all medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Great Britain market need to be registered with the MHRA. There is a grace period for registering:

  • Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021;

  • other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021;

  • Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022; and

manufacturers of Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with Northern Ireland-based Authorised Representatives) must continue to register their devices from 1 January 2021 on the same basis as they do now rather than in line with the above dates.

The Group's lung cancer blood test may be classed as an IVD List B product. It is anticipated that the MHRA wishes to strengthen regulation to protect patients post-Brexit. Changes to regulation could lead to potential delays in obtaining the UKCA CE marking approval, LDT accreditation or potentially FDA 510(k) clearance and there can be no guarantee that the Group's future products will ultimately obtain UKCA, CE marking, LDT or FDA 510(k) clearance or that future UKCA, CE marking, LDT or FDA 510(k) clearance can be obtained within the timescales or the budgets anticipated by the Directors. The Group will closely monitor changes to regulation brought about by the MHRA and work with the MHRA to try to ensure that the Group's products meet any changes in the standards.

Strategic Report for the year ended 31 December 2024 (continued)

Principal risks and uncertainties (continued)

Regulatory environment and the process for obtaining regulatory clearance (continued)

On 21 October 2022, the MHRA announced a 12-month extension of the standstill period on the future Medical Device regime which is a substantial reform of the current framework. This is to ensure that the future regime is robust and reflects the detail required to avoid disruption to supplies, support innovation and enable safe access to Medical Devices for UK patients. It is anticipated that the new regulations will come into force in July 2024. This will provide additional time to develop the legislation and support system readiness.

There are possible further uncertainties as to the current and future fiscal, monetary and regulatory landscape in the UK. There is also uncertainty as to how, when and to what extent the continuing impact of Brexit, the COVID-19 pandemic, risk of a trade war with the USA in response to tariffs, the ongoing armed conflict in Ukraine, the Middle East and potential low levels of economic growth, will have an impact more generally on the economy of the UK and the growth of various industries, consumer confidence, levels of investor activity and confidence in market performance.

Currently the Company's product (monoclonal antibody) is manufactured in the USA and would not therefore be subject to tariffs when sold to US markets.

The UK's exit from the EU may yet lead to a more complicated and uncertain process for obtaining regulatory clearance to market the Group's future products in the UK and the EU. In the event of such complications or delays in obtaining regulatory clearance for marketing in the UK or the EU, the Group will consider giving higher priority to compliance with the LDT and FDA 510(k) clearance process.

Following Brexit, the Group will need to comply with the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 if it is to market its future products in the UK. Failure to comply with additional requirements as a result of regulatory change and/or failure to receive regulatory clearance may adversely impact the Group's ability to develop and market its products which in turn may have an adverse impact on the business of the Group.

Complex research and development processes

Certain elements of the reagents and other components which are planned to be used in the Group's test for lung cancer are complex and bespoke in their nature and may be difficult to reproduce in an optimised manner. Any unexpected delays or issues with this process may have an impact on the Group's anticipated development and commercialisation strategy and its timeline.

Competition and the pace of development in the healthcare industry

The Directors are aware of a number of competitor companies which are seeking to develop, commercialise or market alternative types of tests for the detection of cancer, including lung cancer. Certain competitors already have UKCA, CE of FDA 510K marking or LDT accreditation for lung cancer detection products. Existing or new competitors may have larger resources, greater market presence, economies of scale or a lower cost base than the Group. Diagnosis of lung cancer needs to be made at a much earlier stage through the availability of an accurate in vitro diagnostic test. This is being addressed by a number of different technologies to the Group, for example autoantibody technology and tests on circulating DNA including those based on single nucleotide polymorphisms (SNPs) and gene panels. It is therefore possible that the market may evolve and other tests and companies may provide alternative solutions. Few tests are aimed at early detection (cancer stages 1 and 2) or on reducing significantly the number of false positives achieved via X-Ray and chest CT scans. While many blood tests to detect tumour markers are available or under development, many are hampered as markers may also be produced by normal cells. In contrast, the Group's test is based on technology to find a biomarker in early -stage tumours..

The Group operates within the biotechnology sector, a complex area of the healthcare industry. Rapid scientific and technological change within the biotechnology sector could lead to other market participants creating approaches, products and services equivalent or superior to the diagnostic testing products and services than those to be offered by the Group, which could adversely affect the Group's performance and success. Better resourced competitors may be able to devote more time and capital towards the research and development process, which, in turn, could lead to scientific and/or technological breakthroughs that may materially alter the outlook or focus for markets in which the Group will operate.

Strategic Report for the year ended 31 December 2024 (continued)

Principal risks and uncertainties (continued)

Competition and the pace of development in the healthcare industry (continued)

If the Group is unable to keep pace with the changes in the biotechnology sector and in the wider healthcare industry, the demand for its prospective future testing platforms and associated products and services could fall, which may have a material adverse effect on the Group's business, financial condition, capital resources, results and/or future operations. In addition, certain of the Group's competitors may have significantly greater financial and human resource capacity and, as such, better manufacturing capability or sales and marketing expertise. New companies with alternative technologies and products may also emerge. Any of these events may have a material adverse effect on the Group's business, financial condition, capital resources, results and/or future operations.

Attraction and retention of key management and employees

The successful operation of the Group will depend partly upon the performance and expertise of its current and future management and employees. The loss of the services of certain of these members of the Company's key management, particularly Professor Dawn Coverley and Dr Allan Syms or the inability to identify, attract and retain a sufficient number of suitably skilled and qualified employees may have a material adverse effect on the Group.

CE Marking

If there are restrictions on using the Company's assay as a 'In-House In Vitro Diagnostic device' (IH-IVD) then this would delay the timing of future product sales within the EU.

Complex research and development processes

Certain elements of the reagents and other components which are planned to be used in the Group's test for lung cancer are complex and bespoke in their nature and may be difficult to manufacture at scale in an optimised manner. Any unexpected delays or issues with this process may have an impact on the Group's anticipated development and commercialisation strategy and its timeline.

Ownership and protection of intellectual property rights

The Group's ability to compete will depend in part upon the successful protection of its intellectual property, in particular its patents and know-how. The Group seeks to protect its intellectual property through the filing of patent applications, as well as robust confidentiality obligations on its employees. Filing, prosecuting and defending patents in all countries throughout the world would be prohibitively expensive. It is possible that competitors will use the technologies in jurisdictions where the Group has not yet obtained patent protection in order to develop its own products which will then directly compete against the Group's product.

Future product liability risks

The Group's future business may expose it to potential product liability and indemnity risks. There can be no assurance that the necessary insurance cover will be available to the Group at a commercially acceptable cost or that, in the event of any claim, the level or extent of insurance carried by the Group now or in the future will be adequate, or that a product liability or other claim would not materially and adversely affect the business of the Group.

Lack of manufacturing process

The Group currently has no manufacturing process. Future manufacturing process will be outsourced to a partner specialising in manufacture. These arrangements usually provide for an adequate volume of manufacturing capability. No assurance can be given that a future manufacturing partner (i) can be found to provide a product on commercially acceptable terms and (ii) will achieve and sustain the production yields required to meet the Group's future customers' demand for the Group's products; in either case this could have a material and adverse effect on the Group's business.

Future funding requirements

The Company has raised approximately £0.62m of funds through the issue of new shares in April 2024 and on 21 October 2024 the Group announced an exclusive licensing and partnership agreement with Cizzle BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA and Canada. The Group has since received payments of US\$400,000 due from initial exclusivity fees and advanced royalties as part of guaranteed payments totalling US\$2.4 million over the period ending April 2027. The Group has now extended that agreement, as announced on 16 December 2024,

Strategic Report for the year ended 31 December 2024 (continued)

Principal risks and uncertainties (continued)

Future funding requirements (continued)

to cover the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") triggering early payments totalling US\$250,000 in July 2025 and US\$250,000 in September 2025.

If the Company is unable to raise additional capital when needed or on suitable terms, the Group could be forced to delay, reduce or eliminate future plans or aspirations should the current activity deliver potentially commercially viable results in the future. Any additional equity fundraising to finance opportunities arising may be dilutive for Shareholders. Any debt-based funding, should it be achievable,

may bind the Group to restrictive covenants and curb its operating activities and ability to pay potential future dividends even when profitable. Finally, changes in interest rates could have an adverse impact on the Group's business by increasing the cost of capital and may negatively impact the Group's ability to secure financing on favourable terms.

Timely completion of project milestones to commercialise the Group's technology

The Group must meet project milestones in order to commercialise its technology in line with market expectations and to ensure that its first product reaches the market at the most appropriate time to maximise the market opportunity. The Directors continually review project milestones and action to be undertaken at monthly operational and board meetings but no guarantee can be given that such milestones shall be achieved on time or at all. Material delays to project delivery may, among other things, damage relationships with key suppliers and other business partners and may risk other market entrants building market share which may have an adverse effect of the Group's business. Delays in meeting project milestones may also delay the Group from generating potential revenue from licensing, current royalty deals and antibody sales.

Economic uncertainty

There are significant uncertainties as to the current and future fiscal, monetary and regulatory landscape in the UK. Economic and global political uncertainty, including the continuing impact of Brexit, post COVID-19 pandemic economic correction, the risk of a trade war with the USA, the ongoing armed conflict in Ukraine and potential low levels of economic growth, are likely to put cost pressures on services which the Group requires for both research, development and professional advisory. The Group will continue to negotiate fixed price contracts with its professional advisors, however such contracts will need to be renewed and renegotiated periodically. In addition new adviser contracts may need to be entered into from time to time, most likely on a project to project basis. In each case, fixed prices may be higher than those prices paid by the Group in the past.

Reliance on single source of royalty revenues

If there are delays in the receipt of royalties from a single source this would impact on the Group's expected cash flows.

Key performance indicators (KPI's)

The directors have identified the following KPI's that they feel are the most vital measurements for the Group to monitor given its current stage of development. These KPI's are considered at each board and monthly operational meeting.

Cash management

The directors consider the cash flows for the previous month and the updated rolling cash flow forecast for the Group. At 31 December 2024 the Group had cash balances amounting to £365,000 (2023: £144,000) and no borrowings.

Intellectual Property

Each month the directors review the Group's Intellectual Property Portfolio and the applications and renewals required to maintain this portfolio. The Group's patent portfolio currently includes:

  • CIZ1 Replication Protein
  • Methods and Compounds for diagnosis and treatment of cancer; and
  • Use of a Fibrinogen Capture Agent to detect a CIZ1B variant.

Strategic Report for the year ended 31 December 2024 (continued)

Diversity

The Group is aware of the importance of workplace diversity which includes but is not limited to sex, gender, age, ethnicity and cultural background. The Group's only employees are the directors, which consists of four men and one woman.

Under the FCA's Listing Rule 22, as an Equity shares (transition) entity, the Group is subject to certain Diversity and Inclusion targets. These include: i) at least 40% of the individuals on its board of directors are women; (ii) at least one senior position (chair, chief executive, senior independent director or chief financial officer) on its board of directors is held by a woman; and (iii) at least one individual on its board of directors is from a minority ethnic background. Unfortunately, the Group has been unable to meet these targets during the period, largely due to the small, early-stage nature of the business and the short time since its formation. The Group recognises the benefits of diversity across all areas and believes that a diverse Board is a positive factor in business success, brings a broader, more rounded perspective to decision making, and makes the Board more effective. When recruiting, the Board will endeavour to consider a wide and diverse talent pool whilst also taking into account the optimum make-up of the Board, including the benefits of differences in skills, industry experience, business model experience, sex, race, disability, age, nationality, background and other attributes that individuals may bring.

Corporate Responsibility

The Group consists of five directors who all work from their homes and one director also works at the University of York. As we undertake our research and development activities and manage the affairs of the business and develop our plans for the future our business practices focus on the following areas:

  • Health and Safety, and ensuring that all of our employees operate in a safe environment;
  • Environment, managing our environmental impact in areas of waste, energy and water;
  • Employee support, to ensure that all employees flourish;
  • Ethical Standards, operating at the highest level in all business dealings; and
  • Human Rights Issues, so as to ensure that we carefully select all trading partners with such issues in our minds.

Whist our current levels of engagement do not enable much engagement with the local community, we wish, as our business grows, to have positive interaction with the communities in which we operate.

Climate-Related matters

There is limited scope for the Group to have a major impact on environmental matters at the current phase of the Group but we do undertake and take actions on recycling and energy conservation in our daily activities.

We have considered the Financial Stability Board's Task Force on Climate-related Financial Disclosures (TCFD) recommendations and have reported below our status against the following pillars:

  • Governance the governance around climate- related risks and opportunities;
  • Strategy the actual and potential impacts of climate-related risks and opportunities for the business, strategy, and financial planning;
  • Risk Management the processes for identifying, assessing and managing climate-related risks; and
  • Metrics and Targets the metrics and targets used to assess and manage relevant climate-related risks and opportunities.

We are aware of nature-related matters as we undertake our business but do not believe that this is currently applicable for the current stage of operations in our Group.

a. Governance

The Boards oversight of climate-related risks and opportunities – due to the stage of the business the Group's operations are at a relatively small scale and so therefore its environmental impact is low. The Group consists of five directors with most of its research and development activity outsourced to third party organisations. The Group recognises its responsibility to protect the environment now and as the business scales up into its next phase.

Climate-Related matters (continued)

Managements role in assessing and managing climate-related risks and opportunities – The Board is responsible for the oversight of climate-related matters and for keeping under review the adequacy and effectiveness of the Group's internal control and risk management systems, which include climate-related risks. It is also supported by the work undertaken by our Audit Committee.

b. Strategy

Climate-related risks and opportunities identification – The Group is committed to a net-zero planet and undertaking sustainable research.

Climate-related risks and opportunities impacts – the Board is committed to conserving its natural resources and engaging with those partners and suppliers that have similar objectives. The main part of our research and development activity is undertaken at the University of York and overseen by Professor Dawn Coverley. This work is governed by strict policies on climate-related matters, outlined in Yorks Sustainability Plan (https://www.york.ac.uk/about/sustainability/strategy/). In particular, excessive use of single-use plastics is an issue that concerns the Coverley laboratory. They have adopted a rigorous recycling regime for polypropylene and polystyrene items, which involves decontamination and partitioning of almost all cell culture consumables. This feeds into a department-wide drive and is part of a wider sustainability strategy for a range of items from batteries to equipment. Some of the Group's research and development activity at the University of York involves mammalian cell culture, which uses single-use plastic items, all now recycled. This and other research in the Coverley laboratory at York, is currently in the process of Green Impact Award accreditation.

During 2025 we anticipate that clinical trials will be undertaken by one of our partners. We will seek to ensure that Environmental, Social and Governance ("ESG") will be an important consideration as part of this work.

Resilience of the organisations strategy – the information collected during its work will allow the Board to challenge the Group's strategy to ensure that it is as resilient as possible.

c. Risk Management

Identifying and assessing climate-related risks – the main current risk on environmental matters is to ensure that we undertake our research in a sustainable way. This can be done through our partners to whom this work is outsourced. In the future, we recognise that when we develop a 'Point of Care test', perhaps similar to the Covid-19 tests, that such products are likely to be regarded as 'Bio Waste' and therefore difficult to recycle. It will also be important one day to ensure that such products are packaged and distributed in an environmentally sustainable manner.

Managing climate-related risks – these risks will continue to be managed by the Board as part of its Risk Management Procedures.

Integration into overall risk management – as operations scale up in the future the identification, assessment and effective management of climate-related risks and opportunities will be discussed at board meetings.

d. Metrics and targets

Climate-related metrics - as the Group's operations scale up we will seek to collect, structure and effectively disclose related performance data for material climate-related risks and opportunities identified where relevant.

Scope 1, Scope 2 and Scope 3 emissions -the board will consider adopting Sustainability Accounting Standards Board (SASB) recommended disclosures but this may be dependent upon the business model that the Group adopts in order to seek to maximise shareholder value. E.g. it may be that the Group pursues a licensing model.

Climate-related targets – we have already mentioned that all directors mainly work from home apart from one that is based at the University of York, so business travel is already minimised. This means that energy use and emissions, through remote working, are already minimised. Consequently, no separate disclosures relating to energy consumption and efficiency have been made as the entity consumed less than 40,000 kWh of energy during the period.

Promotion of the Company for the benefit of the Members as a whole

S172 of the Companies Act 2006 requires the Board to promote the Company for the benefit of the members as a whole. In particular, the requirements of s172 are for the Directors to:

  • Consider the likely consequences of any decision in the long term;
  • Act fairly between the members of the Company;
  • Maintain a reputation for high standards of business conduct;
  • Consider the interests of the Company's employees;
  • Foster the Company's relationships with suppliers, customers and others; and
  • Consider the impact of the Company's operations on the community and the environment.

The directors have strived to ensure that these considerations are embedded within its decision-making process.

Decision-making

The day to day operation decisions of the Group have been made by the executive directors. All key decisions of the Group have been made at board meetings involving all directors. The Directors believe that during the year they have acted in the way most likely to promote the success of the Company for the benefit of its members as a whole and have adhered to the requirements set out above that are applicable to the Company given its scope of operations. For example, the Company, does not have any employees other than the directors, so considering employee interests is not currently relevant.

The principal decisions taken by the Group during the year ended 31 December 2024 and since the year end have been summarised in the Chair's Statement on pages 2 to 4 and are summarised as follows:

Decision: to raise new monies for the Company to ensure a sound financial base. Context

On 26 March 2024 the Company announced that it has undertaken a conditional placing of 31,050,000 new ordinary shares of 0.01p each ("Ordinary Shares") in the Company (the "Placing") at a price of 2 pence per share (the "Issue Price") raising approximately £0.62 million before expenses for the Company. The net proceeds of the Placing will be utilised towards completing the Company's first proposed commercial test to detect CIZ1B, further protect the Company's Intellectual Property (IP), progress the Company's research with the University of York and for general corporate purposes. Upon completion of the Placing, the Company intends to terminate the £500,000 loan facility agreement with E3 Fund SP entered into on 20 September 2022. This facility has not been drawn down. The Company also agreed to issue 1,500,000 new Ordinary Shares at 2p per new ordinary share in satisfaction of a payment of £30,000 for professional advisory services to Novum Securities Limited.

Stakeholder considerations (Shareholders)

The raising of new finance ensures that the Company has a sound financial platform from which to develop the Group's activities.

Decision-making (continued)

Decision: to invest in Product Development , Clinical Evaluation and future research.

Context

Throughout 2024, the Group continued to work with external expert partners and suppliers and in July entered into a strategic agreement with BBI Solutions ("BBI"), the world's largest independent producer of immunodiagnostic reagents, to supply its first order of commercial propriety monoclonal antibodies. The initial order was manufactured at their ISO 13485-certified facilities and is expected to support up to 5000 assays. This has now been delivered and distributed to our US partners and is crucial for advancing the clinical evaluation process and in meeting a key milestone in bringing the test to market.

The continuing agreement with the University of York and extended access to state-of-the-art facilities and world leading scientists has again achieved important technical and product milestones including the production of molecular tools, development and quality assessment of monoclonal antibodies, clinical evaluation studies and in optimising the standard operating procedure ("SOP") which together with our commercial grade monoclonal antibodies provides the basis for rolling out a scalable, noninvasive, cost effective immunoassay for CIZ1B biomarker testing in early lung cancer.

In terms of future research, the team at the University of York under the leadership of Professor Dawn Coverley will be evaluating how the Group's CIZ1B biomarker may have use point of care devices and in other cancers.

In September, the Group announced it had been selected by the Moffitt Cancer Center ("Moffitt"), the number one cancer hospital in Florida and the Southeast USA, to test patients with suspicious lung nodules in a clinical evaluation using the Company's proprietary CIZ1B biomarker assay.

With multiple sites and over 7000 employees, Moffitt is the only US National Cancer Institutedesignated 'Comprehensive Cancer Center' based in Florida. They have developed a comprehensive lung cancer screening programme that is among the best in the United States, which has resulted in them being named a Screening Center of Excellence by the GO2 Foundation for Lung Cancer.

As part of Moffitt's Phase 2 programme, "Using Biomarkers for Diagnosis, Risk Stratification of Posttreatment Recurrence and Long Term Survival of Lung Cancer", a large observational prospective study in patients with suspicious indeterminant (undiagnosed) lung nodules seen in the Lung Cancer Early Detection (LEAD) Center Lung Nodule Clinic, led by its Director Dr. Lary Robinson, the Company will for the first time be analyzing patient blood samples to determine biomarker accuracy in predicting whether or not a nodule is likely to be cancer. The study follows US nationally recommended guidelines and will be using the first batch of the Company's new commercial monoclonal antibody, to provide new sensitivity and specificity data of the CIZ1B biomarker blood test in the diagnosis of early-stage lung cancer in people with indeterminant lung nodules. The blood sample tests for CIZ1B will be conducted in Professor Dawn Coverley's laboratory at the University of York.

Stakeholder considerations (Shareholders)

The decisions taken have enhanced the Group's Product Development, Clinical Evaluation and research and development capabilities.

Decision-making (continued)

Decision: to achieve Global Market Access through building strong partnerships.

Context

The Group has continued to develop its collaborations with existing partners in the USA and China as part of its global licensing strategy to deliver shareholder value through royalty payments and potential benefits arising from equity participation in the partner companies where possible.

On 21 October 2024 the Group announced an exclusive licensing and partnership agreement with Cizzle BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA and Canada. The Group has since received payments of US\$400,000 due from initial exclusivity fees and advanced royalties as part of guaranteed payments totalling US\$2.4 million over the period ending April 2027. The Group has now extended that agreement, as announced on 16 December 2024, to cover the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") triggering early payments totalling US\$250,000 in July 2025 and US\$250,000 in September 2025.

In addition, the Group will benefit from its equity participation in Cizzle BIO.

On 24 March 2025, the Group announced that its licensing partner Cizzle Bio had appointed iGenomeDX, a specialist clinical diagnostics laboratory to launch the Group's first commercial CIZ1B biomarker test in the USA. iGenomeDX is a Commission on Office Laboratory Accreditation ("COLA") accredited and Clinical Laboratory Improvement Amendments ("CLIA") certified clinical laboratory and has been establishing operating and quality systems ahead of offering the test to clinicians for the first time.

The appointment of iGenomeDX by BIO, is an important step in the Group's plan to achieve commercial sales by providing an accredited facility to launch the CIZ1B biomarker test. The accreditation process involved an evaluation of a laboratory's operations, including its testing procedures, quality control, personnel qualifications, and compliance with regulatory requirements. Labs that achieve COLA accreditation demonstrate a commitment to maintaining high standards of accuracy, reliability, and patient safety in diagnostic testing to ensure they meet CLIA standards and can legally operate.

The successful completion of the operational and quality systems programme is necessary for launching a cost-effective and scalable version of the CIZ1B biomarker assay with rigorous quality control requirements to meet expected reproducibility and sensitivity. This will demonstrate the test is commercially scalable and can be rolled out as a global solution to help reduce premature cancer deaths and improve survival rates and quality of life for cancer patients.

Stakeholder considerations (Shareholders)

The decisions taken have enhanced the Group's Global Market Access.

Decision-making (continued)

Decision: to strengthen the Board and Leadership Team

Context

Professor Dawn Coverley (Chief Scientific Officer, "CSO")

On 2 Jan 2025, to directly support and accelerate the Company's global licensing and partnership strategy to bring its non-invasive, cost effective, CIZ1B biomarker lung cancer blood test to market in 2025, Professor Dawn Coverley, Founder and Non-Executive Director ("NED") of Cizzle Biotechnology was appointed Chief Scientific Officer ("CSO"), an executive role on the board of the Company.

The change in role from NED to CSO, enables Dawn to allocate more of her expert time to directly support the Company's licensing partners, particularly in the USA, to accredited laboratory partners, helping them to achieve CLIA (Clinical Laboratory Improvement Amendments) LDT (Laboratory Developed Test) accreditation and identify and lead new non-dilutive grant funded research and clinical evaluations.

Dawn is currently a professor and principal investigator of a research laboratory at the University of York, studying how specialised cells are protected from age-related decay. After a first degree in Genetics (Leicester), and a PhD in Biochemistry (Cancer Research UK), she completed postdoctoral training at the University of Cambridge, then moved to the University of York to establish an independent research group in 2002, supported by the Lister Institute of Preventive Medicine.

Dawn will reduce a number of her current teaching and scientific roles at the University of York in order to devote sufficient time to the Company's activities, whilst maintaining a number of key roles, including leadership of her research group and management of the Company's existing research and development contract at the University of York.

The timing of this appointment coincides with the successful completion of the technical programme which confirms that the most cost-effective and scalable version of the CIZ1B biomarker assay for CLIA accreditation is an ELISA. The rigorous quality control programme undertaken has been able to demonstrate equivalence with initial manual laboratory tests and with the BioTechne ProteinSimple capillary Western system. Results have shown sensitivity equivalent to published CIZ1B lung cancer studies *, and an ability to correctly identify people with lung cancer with few false negative results. This is another major step in demonstrating that the Company's lung cancer blood test is both cost effective and a commercially scalable global solution to reduce premature cancer deaths and improve survival rates and quality of life for cancer patients.

Matthew Bower (Non-Executive Director, "NED")

Matt Bower is an experienced company executive and adviser with a track record as a director and secretary of private equity backed and listed companies, across a broad range of company and technology related activities was appointed as a Non-Executive Director of the Board on 21 March 2025. He is engaged as a strategic advisor and mentor to the board of directors of a number of high growth trading and technology companies, and a director of a number of private companies.

Matt will sit on both the Company's audit and remuneration committees, alongside the Company's independent Non-Executive Director, John Treacy, replacing Prof Dawn Coverley who recently moved from her role as a NED to Chief Scientific Officer, as announced on 2 January 2025.

Stakeholder considerations (Shareholders)

The decisions taken have enhanced the Group's Board and Leadership Team.

This report was approved by the board on 30 April 2025 and was signed on its behalf by:

Allan Syms Director

Directors' Report for the year ended 31 December 2024

The directors present the annual report and audited financial statements for the year ended 31 December 2024.

Principal activity, business review and future developments

On 14 May 2021, the Company's ordinary shares were admitted to the Standard-Listing of the London Stock Exchange. Also on that date, the Company completed the reverse acquisition of CBL. On 29 July 2024, the new UK Listing Rules published by the FCA came into effect and the Company's listing moved to a new FCA listing category, the Equity Shares (transition) category.

The Group's principal activity since 14 May 2021 has been the early detection of lung cancer via the development of an immunoassay test for the CIZ1B biomarker.

The Statement of Group Comprehensive Income is set out on page 42. A review of the Group's trading during the year, its position at the year-end, post balance sheet events, and its prospects for the future are set out in the Chair's Statement and the Strategic Report.

Dividends

No dividend is proposed in respect of the year (2023: £Nil).

Financial risk management

Information in respect of financial risk management objectives and policies, exposure to price, credit, liquidity and cash flow risks, and current trading and trading outlook for the Group are outlined in Note 4.

Directors

The directors of the Company who served during the year and since 31 December 2024 are listed below:

Directors Function

Allan Syms Executive Chair
Nigel Lee Finance Director
Dawn Coverley Chief Scientific Officer
John Treacy Non-Executive Director
Matt Bower Non-Executive Director since 21 March 2025

Board Responsibility and Corporate Governance Statement

The Board is responsible for approving the interim and annual financial statements, formulating and monitoring the Group's strategy, approving financial plans and reviewing performance, as well as complying with legal, regulatory and corporate governance matters. The Board is committed to maintaining appropriate standards of corporate governance and, as detailed below on page 22, has concluded that it will continue to adopt the Quoted Companies Alliance's Corporate Governance Code.

Employees

At 31 December 2024 the total number of employees in the Company comprised of 4 employees (2023: 4), who were all directors.The Group's employment policies are designed to attract, retain and motivate the very best staff for each role in the Group, recognising that this can only be achieved through equal opportunities regardless of sex, gender, race, religion or disability. Regular meetings were held by the directors to discuss the performance of the Group as a whole. Financial and economic factors were dealt with in this context. Information concerning employees and their remuneration is given in Note 8.

Climate-related matters

We believe that the Company has made climate-related financial disclosures consistent with the Task force on Climate-related Financial Disclosures ("TCFD") recommendations and recommended disclosures within its Strategic Report on pages 12 and 13.

Directors' Report for the year ended 31 December 2024 (continued)

Capital structure

Details of the issued share capital are set out in Note 15. On recognition of the reverse takeover of CBL on 14 May 2021 the Group had 3 classes of share:

  • New Ordinary Shares of 0.01p each.
  • Deferred 'A' shares of 0.01p each.
  • Deferred 'A' Shares of 0.99p each.

None of these shares have any rights to fixed income and only new ordinary shares carry the right to one vote per share at general meetings of the Company. There are no specific restrictions on the size of a holding or on the transfer of New Ordinary Shares, which are both governed by the general provisions of the Articles of Association and prevailing legislation. The directors are not aware of any agreements between holders of the Company's shares that may result in restrictions on the transfer of securities or on voting rights.

Details of employee share option schemes are set out in Note 1. No share options were exercised during the year (2023: Nil).

No person has any special right of control over the Company's share capital and all issued shares are fully paid.

The appointment and replacement of directors of the Company is governed by its Articles of Association, the Companies Act 2006 and related legislation. The Articles themselves may be amended by special resolution of the shareholders. The current Articles have been in place for some years and are in the process of being reviewed and updated. It is anticipated that updated articles will be proposed for approval at the forthcoming Annual General Meeting.

Directors' Interests

The Interest of the Directors in the Company's shares is noted in the Remuneration Report and has not changes since 31 December 2024.

Donations

No charitable or political donations were made during the year (2023: £Nil).

Share issues

Details of shares issued during the year are set out in Note 16.

Going concern

Current Funding

The Group's cash balance as at 31 December 2024 was £365,000 and there were no borrowing facilities at that date. On 26 March 2024 the Group announced that it has undertaken a conditional placing of 31,050,000 new ordinary shares of 0.01p each ("Ordinary Shares") in the Company (the "Placing") at a price of 2 pence per share (the "Issue Price") raising approximately £0.62 million before expenses for the Company. The net proceeds of the Placing will be utilised towards completing the Company's first proposed commercial test to detect CIZ1B, further protect the Company's Intellectual Property (IP), progress the Company's research with the University of York and for general corporate purposes.

The Directors have adopted the going concern basis in preparing the financial statements for the year ended 31 December 2024. In reaching this conclusion, the Directors have considered current trading and the current and projected funding position for approximately 20 months from the date of approval of the financial statements through to 31 December 2026. The forecasts have been prepared using a number of scenarios – a base case assumes receipt of minimum royalty payments and an 'Accelerated Growth' model assumes that revenues will be earned from royalties in Europe and the Rest of the World, more investment into research and development activities and expanding the UK team.

These scenarios show that the Group is reliant upon the timely receipt of the first \$1m (approx. £570,000) of Guaranteed Minimum Royalty Payments (GMP) from Cizzle Bio Inc ("Bio"), in respect of the Group's Royalty Agreement covering North America and The Caribbean. The receipt of two GMP instalments of \$250,000

Directors' Report for the year ended 31 December 2024 (continued)

(approx. £190k) in July and September 2025 is dependent on Bio signing a deal with a Caribbean hospital (recently signed) and would represent an advance of the first \$1m with the balance of a further receipt of GMP of \$500k (approx. £380k) is expected to be received in January 2026.The receipt of these royalties is not dependent upon Bio's appointed Research Laboratory, iGenomeDX, achieving a CLIA accreditation. However, there remains uncertainty if Bio will be able to make these payments as it is dependent on raising further funds. Should these royalty payments be delayed or not materialise, then the company may be required to raise additional funding to continue to meet its obligations.

Conclusion

After taking into account these conditions, it indicates that a material uncertainty exists that may cast significant doubt on the group and company's ability to continue as a going concern. These financial statements do not include any adjustments that would result from the going concern basis of preparation being inappropriate.

Post Balance Sheet event

The Group announced on 28 April 2025 that its licensing partner Cizzle Bio Inc ("BIO" or "Cizzle Bio") has executed its first contract in the Caribbean as part of the extension to its exclusive licensing and partnership agreement with the Company for the USA and Canada, as announced on 16 December 2024. The nonexclusive Laboratory Services Agreement signed by BIO with Doctors Hospital (Chrissie Tomlinson Memorial Hospital - CTMH) in the Cayman Islands triggers the early royalty payments due to the Company from BIO, totalling US\$500,000 in July and September 2025, as part of the advanced minimum royalty of US\$1 million previously all due on 21 January 2026.

Disclosure of information to auditor

The directors who held office at the date of approval of this Directors' report confirm that, so far as they are aware, there is no relevant audit information of which the Company's auditor is unaware; and each Director has taken all steps that he ought to have taken as a Director to make himself aware of any relevant audit information and to establish that the Company's auditor is aware of that information.

Auditor

The existing auditors of the Company are PKF Littlejohn LLP and a resolution for their re-appointment will be put to the Annual General Meeting.

Annual General Meeting

The Annual Report is made available to shareholders at least 21 clear days' notice before the Annual General Meeting ("AGM") along with the notice of the AGM. Shareholders are given the opportunity to vote on each separate resolution proposed at the AGM. The Company counts all proxy votes and will indicate the level of proxies lodged for each resolution, after it has first been dealt with by a show of hands.

Website publication

The Directors are responsible for ensuring the annual report and the financial statements are made available on a website. Financial statements are published on the Group's website in accordance with legislation in the United Kingdom governing the preparation and dissemination of financial statements, which may vary from legislation in other jurisdictions. The maintenance and integrity of the Group's website is the responsibility of the Directors. The Directors' responsibility also extends to the ongoing integrity of the financial statements contained therein.

Approved by the Board of Directors and signed by order of the Board

Allan Syms Director, 30 April 2025

Statement of Directors' Responsibilities

The directors are responsible for preparing the strategic report, the directors' report and the financial statements in accordance with applicable law and regulations.

Company law requires the directors to prepare financial statements for each financial year. Under that law the directors have elected to prepare the Group and Company financial statements in accordance with UK-adopted international accounting standards. Under company law the directors must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the Group and Company and of the profit or loss of the Group and Company for that period.

In preparing these financial statements, the Directors are required to:

  • select suitable accounting policies and then apply them consistently;
  • make judgements and accounting estimates that are reasonable and prudent;
  • state whether they have been prepared in accordance with UK-adopted international accounting standards, subject to any material departures disclosed and explained in the financial statements; and
  • prepare the financial statements on the going concern basis unless it is inappropriate to presume that the Group and Company will continue in business.

The Directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Group and Company's transactions and disclose with reasonable accuracy at any time the financial position of the Group and Company and enable them to ensure that the financial statements comply with the requirements of the Companies Act 2006. They are also responsible for safeguarding the assets of the Group and Company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.

They are also responsible to make a statement that they consider that the Annual Report and Financial Statements, taken as a whole is fair, balanced and understandable and provides the information necessary for the shareholders to assess the Group and Company's position and performance, business model and strategy.

Directors' Responsibility Statement Pursuant to Disclosure and Transparency Rules

Each of the Directors, whose names and functions are listed on page 1, confirm that, to the best of their knowledge and belief:

  • the financial statements prepared in accordance with UK-adopted international accounting standards, give a true and fair view of the assets, liabilities, financial position and loss of the Group and Company; and
  • The Annual Report and financial statements, including the Business review, includes a fair review of the development and performance of the business and the position of the Group and Parent Company, together with a description of the principal risks and uncertainties that they face.

Corporate Governance Statement

The Directors recognise the importance of sound corporate governance. The directors continue to adopt the Quoted Companies Alliance's Corporate Governance Code ("the QCA Code"). The Directors intend adopting the QCA Code published on 13 November 2023 ("2023 Code") in the Company's Annual Report for the year ended 31 December 2025. As is permitted by the guidance set out by the QCA, the transition period of 12 months following 1 April 2024 is being utilised to put in place measures to embrace the key updates to the QCA code where possible. In addition, the Directors have adopted a code of conduct for dealings in the shares of the Company by directors and employees and are committed to maintaining the highest standards of corporate governance. During 2024 Allan Syms has continued as Executive Chair of the Company.

The corporate governance arrangements that the Board has adopted are designed to ensure that the Company delivers long term value to its shareholders and that shareholders have the opportunity to express their views and expectations for the Company in a manner that encourages open dialogue with the Board. The Board recognises that their decisions regarding strategy and risk will impact the corporate culture of the Company as a whole and that this will impact the performance of the Company. The Board is very aware that the tone and culture set by the Board will greatly impact all aspects of the Company as a whole and the way that employees behave.

The Company's activities have been focussed on translating the research and development activities of the Group that have been developed over many years by Professor Dawn Coverley and her team at The University of York, into a marketable product. The Company is committed to respectful dialogue with its suppliers, partners and potential customers. It is a crucial part of the Company to have sound ethical values and behaviours in its undertakings to successfully achieve its corporate objectives.

The Board places great importance on this aspect of corporate life and seeks to ensure that this flows through all that the Company does.

After the end of the financial period under review, the Company announced the appointment Professor Dawn Coverley as Chief Scientific Officer and Edwin Matthew (Matt) Bower as a Non-Executive Director, The Board currently consists of three executive and two non-executive directors and does not have a CEO. The Board continues to consider whether it would be appropriate to seek to appoint additional non-executive and/or executive directors but at this time believes that appropriate oversight of the Company is provided by the currently constituted Board. This view will continue to be reviewed by the Board.

John Treacy Non-Executive Director

Corporate Governance Statement (continued)

The QCA Code sets out 10 principles which should be applied. These are listed below together with a short explanation of how the Company applies each of the principles. Where the Company does not fully apply each principle an explanation as to why has also been provided:

Principle One–- Business Model and Strategy

The Group's vision to help make a global shift in lung cancer survival through accurate, low cost, noninvasive early detection at scale and to deliver its mission to transform lung cancer survival, by empowering healthcare professionals and patients to enable curative medical intervention using a groundbreaking and affordable diagnostic blood test that can detect lung cancer early. The Board's strategy to deliver its mission during 2024 has been able to continue with its research and development activity and in particular had adopted a strategy of developing the Group's prototype test into a commercial LDT, CE marked and/or FDA 510(k) cleared diagnostic immunoassay that can be licensed globally and readily performed as a sufficiently reliable test in a hospital setting.

Principle Two–- Understanding Shareholder Needs and Expectations

The Board is committed to maintaining good communication and having constructive dialogue with its shareholders. Institutional shareholders and analysts have the opportunity to discuss issues and provide feedback at meetings with the Company. In addition, all shareholders are encouraged to attend the Company's Annual General Meeting. Investors also have access to current information on the Company though its website, https://cizzlebiotechnology.com and via Allan Syms, Executive Chair who is available to answer investor relations enquiries through IFC Advisory Limited ([email protected]).

Principle Three–- Stakeholder Responsibilities

The Board recognises that the long-term success of the Company is reliant upon the efforts of the employees of the Company and its contractors, suppliers and regulators. The Board has put in place a range of processes and systems to ensure that there is close Board oversight and contact with its key resources and relationships. Currently the directors of the Company are the Group's only employees but it has systems in place whereby the effectiveness of the board is reviewed and discussed.

Principle Four–- Risk Management

In addition to its other roles and responsibilities the Audit and Compliance Committee is responsible to the Board for ensuring that procedures are in place, and are being effectively implemented to identify, evaluate and manage the significant risks faced by the Company. The risk assessment matrix below sets out those risks, and identifies their ownership and the controls that are in place. This matrix is updated as changes arise in the nature of risks or the controls that are implemented to mitigate them. The Audit Committee reviews the risk matrix and the effectiveness of scenario testing on a regular basis. The following principal risks, and controls to mitigate them, have been identified during 2024:

Activity Risk Impact Control(s)
Financial Early-stage revenue
business
Revenues are not generated
to support the development
and commercialisation of the
Group's technology.
Regular appraisal of
project milestones.
Healthcare Industry Pace of development
in
the
healthcare
industry
The Group's technology may
be
superseded
by
other
competitor technologies.
Continual
monitoring
of competitor products
and
alternative
solutions.
Management
and
employees
Retention of key
staff
The loss of key members of
staff could have an adverse
impact
on
the
pace
of
development.
Ensuring
that
key
employees
have
incentives
to
ensure
that they do not wish to
leave.
Research
and
Development
Complex processes Additional
costs
if
development
takes
longer
than anticipated.
Regular appraisal of
project milestones and
consideration of a
variety of strategies.
Patents
and
other
intellectual
property
rights (IPR)
Infringement of other
patents, IPR
Additional costs of defending
any IPR claims and/or delays/
additional costs in current
programme of research and
development.
Regular monitoring of
third party patents/
IPR with patent
advisers.

Corporate Governance Statement (continued)

Principle Four–- Risk Management (continued)

The Company has already established procedures, as represented by this and previous years' statements, for the purpose of providing a system of internal control. In addition, there were a range of Company policies that were reviewed at least annually by the Board. These Company policies covered matters such as share dealing, insider legislation and expenses. The directors consider that an internal audit function is not considered necessary or practical due to the size of the Company and the close day to day control exercised by the directors. The directors will continue to monitor the need for new systems of internal control and an internal audit function.

The annual review of internal control and financial reporting procedures did not highlight any issues warranting the introduction of an internal audit function.

Principle Five–- A Well-Functioning Board of Directors

During 2024 the composition of the board has been two executive directors and two non-executive directors. Allan Syms is Executive Chair and Nigel Lee is the Finance Director. The non-executive directors have continued to be John Treacy and Professor Dawn Coverley. The time commitment formally required by the Company is an overriding principal that each director will devote as much time as is required to carry out the roles and responsibilities that the director has agreed to take on. All directors of the Company are part-time. On 1 January 2025 Professor Dawn Coverley, Chief Scientific Officer, became an executive director. On 21 March 2025 Matt Bower became a non-executive director. Biographical details of the current directors are set out on page 4.

Executive and non-executive directors are subject to re-election intervals as prescribed in the Company's Articles of Association. At each Annual General Meeting one-third of the Directors, who are subject to retirement by rotation shall retire from office. They can then offer themselves for re-election. The letters of appointment of all directors are available for inspection at the Company's registered office during normal business hours.

The Executive Chair and Finance Director both receive a salary for their services as a director which is approved by the Board, being mindful of the time commitment and responsibilities of their roles and of current market rates for comparable organisations and appointments. They are also reimbursed for travelling and other incidental expenses incurred on Group business.

The Non-Executive Directors receive payments under appointment letters which are terminable by three months' notice by either party.

The Board encourages the ownership of shares in the Company by Executive and Non-Executive Directors alike and in normal circumstances does not expect Directors to undertake dealings of a short-term nature. The Board considers ownership of Company shares by Non-Executive Directors as a positive alignment of their interest with shareholders. The Board will periodically review the shareholdings of the Non-Executive Directors and will seek guidance from its advisors if, at any time, it is concerned that the shareholding of any Non-Executive Director may, or could appear to, conflict with their duties as an independent Non-Executive Director of the Company or their independence itself. Directors' emoluments, including Directors' interest in share options over the Company's share capital, are set out in Note 15.

The Board has established that it will meet on at least 6 times throughout the year. It has established an Audit Committee and a Remuneration Committee, particulars of which appear hereafter. The Board agreed that appointments to the Board are made by the Board as a whole and so has not created a Nominations Committee.

Corporate Governance Statement (continued)

Principle Five–- A Well-Functioning Board of Directors (continued)

Attendance at Board and Committee Meetings

The Board retains full control of the Company with day-to-day operational control delegated to Executive Directors. The full Board meets at least every other month and on any other occasions it considers necessary. During 2024 there were twelve Board meetings, one Remuneration Committee meeting and one Audit Committee meeting. All Board meetings were attended by all existing directors during 2024. The Audit Committee meeting was attended by both members of the Audit Committee with the executive directors in attendance. The Remuneration Committee meeting was attended by only members of the Remuneration Committee.

Principle Six–- Appropriate Skills and Experience of the Directors

Directors who served during 2024:

Throughout 2024 the executive directors have been Allan Syms (Executive Chair) and Nigel Lee (Finance Director). The Non-Executive directors have been John Treacy (specialising in corporate governance, capital markets, legal matters) and Professor Dawn Coverley (cell biologist and expert in cancer related research).

On 1 January 2025, Professor Dawn Coverley (Chief Scientific Officer), was appointed an executive director and on 21 March 2025, Matt Bower was appointed a non-executive director (specialising as a strategic advisor).

As a small business, the Group does not have a formal diversity policy. The Group recognises the benefits of diversity across all areas and believes that a diverse Board is a positive factor in business success, brings a broader, more rounded perspective to decision making, and makes the Board more effective. When recruiting, the Board will endeavour to consider a wide and diverse talent pool whilst also taking into account the optimum make-up of the Board, including the benefits of differences in skills, industry experience, business model experience, sex, gender, race, disability, age, nationality, background and other attributes that individuals may bring.

The current directors of the Company are as follows are detailed on page 6.

Principle Seven–- Evaluation of Board Performance

Internal evaluation of the Board, the Committee and individual directors is seen as an important step in the development of the Board. During 2024 separate meetings were held with the Chair and each director to review the effectiveness of the board. Evaluation criteria take into account business planning and financial reporting together with performance against key milestones, board composition, constitution, diversity and succession planning. As we further progress the commercialisation of the Group's technology, the Company recognises the need to draw further expertise into the board when appropriate. This will be undertaken on an annual basis in the form of peer appraisal, questionnaires and discussions to determine the effectiveness and performance in various areas as well as the directors' continued independence.

Principle Eight–- Corporate Culture

During 2024, the Board recognised that their decisions regarding strategy and risk will impact the corporate culture of the Company as a whole and that this will impact the performance of the Company. The Board is very aware that the tone and culture set by the Board will greatly impact all aspects of the Company as a whole and the way that employees behave. A large part of the Company's activities was centred upon addressing customer and market needs. Therefore, the importance of sound ethical values and behaviours is crucial to the ability of the Company to successfully achieve its corporate objectives. The Board places great importance on this aspect of corporate life and seeks to ensure that this flows through all that the Company does. The Board assessment of the culture within the Company at the present time is one where there is respect for all individuals and there is open dialogue within the Company.

Corporate Governance Statement (continued)

Principle Nine–- Maintenance of Governance Structures and Processes

Ultimate authority for all aspects of the Company's activities rests with the Board. The Board has adopted a Financial Position and Prospects Board Memorandum which summarises financial reporting procedures and establishes procedures to ensure that it meets all regulatory requirements for accounting, financial reporting and related obligations. This includes matters which are reserved to the Board and the division of responsibilities between the executive and non-executive directors. The Chair is responsible for the effectiveness of the Board.

Audit Committee

During 2024 the Audit Committee has consisted of John Treacy (Chair) and Professor Dawn Coverley. It meets as required and specifically to review the Interim Report and Annual Report, and to consider the suitability and monitor the effectiveness of internal control processes. There was one meeting of the Audit Committee during 2024. The Audit Committee also reviews the findings of the external auditor and reviews accounting policies, material accounting judgements and risk and control framework. On 1 January 2025 Professor Dawn Coverley became an executive director and so stepped down from the Audit Committee. During March 2025 Matt Bower joined the Audit Committee.

The independence and effectiveness of the external auditor is reviewed annually. The possibility of undertaking an audit tender process is considered on a regular basis. The Company's policy is to ensure that the Company's audit is put out to tender at least once in every 10 years. The Current auditors were appointed in respect of the Company's audit for the year ended 31 December 2018. At each Annual General Meeting a resolution is proposed for the re-appointment of auditors. There are no contractual restrictions existing on the choice of auditors. The Audit Committee meets at least once a year with the auditor to discuss their independence and objectivity, the Annual Report, any audit issues arising, internal control processes, appointment and fee levels and any other appropriate matters. The fees in respect of audit services are set out in Note 7.

Remuneration Committee

During 2024 the Remuneration Committee has consisted of John Treacy (Chair) and Professor Dawn Coverley. The purpose of the Remuneration Committee is to ensure that the Executive Directors and other employees are fairly rewarded for their individual contribution to the overall performance of the Company. The Committee considers and recommends to the Board the remuneration of the Executive Directors and is kept informed of the remuneration packages of senior staff and invited to comment on these. There was one Remuneration Committee meeting during 2024. The Board retains responsibility for overall remuneration policy. The Remuneration Committee recommends to the Board the remuneration packages by reference to individual performance and uses the knowledge and experience of the Committee members, published surveys relating to similar companies and market changes generally. The Remuneration Committee has responsibility for recommending any long-term incentive schemes.

On 1 January 2025 Dawn Coverley ceased to be a member of the Remuneration Committee and Matt Bower became a member on 21 March 2025.

The Board determines whether or not Executive Directors are permitted to serve in roles with other companies. Such permission would only be granted on a strictly limited basis, where there are no conflicts of interest or competing activities and providing there is not an adverse impact on the commitments required to the Company. Earnings from such roles would be required to be disclosed to the Chair.

During 2024 there were two main elements of the remuneration package for Executive and Non-Executive Directors and former employees:

  1. Basic salaries: Basic salaries are recommended to the Board by the Remuneration Committee, taking into account the performance of the individual and the rates for similar positions in comparable companies. No benefits in kind are currently available to Executive Directors. The directors agreed to freeze their remuneration for two years until March 2025 (now expired) as noted in the Directors Remuneration Report on page 32.

  2. Share options: The Company operates unapproved share option schemes for Executive Directors and some non-executive directors to motivate those individuals through equity participation. Exercise of share options under the schemes is subject to specified exercise periods and compliance with the Scheme Rules and the rules of the London Stock Exchange. The schemes are overseen by the Remuneration Committee which recommends to the Board all grants of share options based on the Remuneration Committee's assessment of personal performance and specifying the terms under which eligible individuals may be invited to participate. It is intended that the performance related elements of

Corporate Governance Statement (continued)

remuneration form a significant proportion of the total remuneration package of Executive Directors and be designed to align their interests with those of shareholders. In this development phase of the Company the Remuneration Committee currently considers that the best alignment of these interests is through the continued use of incentives for performance through the award of share options.

Non-executive Directors

The Board has adopted guidelines for the appointment of non-executive directors which have been in place and which have been observed throughout the year. These provide for the orderly and constructive succession and rotation of the non-executive directors insofar as they will be appointed for an initial term of three years and may, at the Board's discretion believing it to be in the best interests of the Company, be appointed for subsequent terms. In accordance with the Companies Act 2006, the Board complies with: a duty to act within their powers; a duty to promote the success of the Company; a duty to exercise independent judgement; a duty to exercise reasonable care, skill and diligence; a duty to avoid conflicts of interest; a duty not to accept benefits from third parties and a duty to declare any interest in a proposed transaction or arrangement.

Principle Ten–- Shareholder Communication

The Board is committed to maintaining good communication and having constructive dialogue with its shareholders. Institutional shareholders and analysts have the opportunity to discuss issues and provide feedback at meetings with the Company. In addition, all shareholders are encouraged to attend the Company's Annual General Meeting. Investors also have access to current information on the Company though its website, https://cizzlebiotechnology.com and via Allan Syms, executive Chair who is available to answer investor relations enquiries through IFC Advisory Limited ([email protected]).

Directors' Remuneration Report for the year ended 31 December 2024

The Company has established a remuneration committee. The Committee reviews the scale and structure of the Directors' fees, taking into account the interests of shareholders and the performance of the Group and directors.

The items included in this report are unaudited unless otherwise stated.

Statement of Cizzle Biotechnology Holdings PLC Policy on Directors' Remuneration by the Chair of the Remuneration Committee

As Chair of the Remuneration Committee, I have pleasure in introducing our Directors' Remuneration Report. One of the Remuneration Committee's aims is to provide clear, transparent remuneration reporting for our shareholders which adheres to the best practice corporate governance principles that are required for listed companies.

A key focus of the Directors' Remuneration Policy is to align the interests of the Directors to the long-term interests of the shareholders and aims to support a high-performance culture with appropriate rewards for meeting the Group's objectives without unnecessary risk-taking. This is underpinned through the operation of incentive plans.

Key activities of the Remuneration Committee

The key activities of the Remuneration Committee are to:

  • determine and agree with the board the framework or broad policy for the remuneration of the Company's Chair and the executive directors including pension rights and compensation payments. The remuneration of non-executive directors shall be a matter for the board or the shareholders (within the limits set in the articles of association). No director or senior manager shall be involved in any decisions as to their own remuneration;
  • recommend and monitor the level and structure of remuneration for senior management taking into account all factors which it deems necessary including relevant legal and regulatory requirements and the provisions and recommendations of the UK Corporate Governance Code (insofar as it applies to the Company) and other relevant guidance. These will be subject to annual review. The objective of such policy shall be to attract, retain and motivate the executive management of the Company without paying more than necessary. The remuneration policy bears in mind the Company's appetite for risk and be aligned to the Company's long term strategic goals. A significant proportion of remuneration should be structured so as to link rewards to corporate and individual performance and be designed to promote the long term success of the Company;
  • review and have regard to the pay and employment conditions across the Company or Group, especially when determining salary increases;
  • review the ongoing appropriateness and relevance of the remuneration policy;
  • approve the design of, and determine targets for, any performance related pay schemes operated by the Company and approve the total annual payments made under such schemes;
  • review the Company's arrangements for its employees to raise concerns, in confidence, about possible wrongdoing in financial reporting or other matters. The Committee shall ensure that these arrangements allow proportionate and independent investigation of such matters and appropriate follow up action;
  • review the design of all share incentive plans for approval by the board and shareholders. For any such plans, determine each year whether awards will be made, and if so, the overall amount of such awards, the individual awards to executive directors, Company Secretary and other senior executives and the performance targets to be used;
  • determine the policy for, and scope of, pension arrangements for each executive director and other senior executives;

Directors' Remuneration Report for the year ended 31 December 2024 (cont'd)

Key activities of the Remuneration Committee (cont'd)

  • determine the total individual remuneration package of the Chair, each executive director, the Company Secretary and other senior executives including bonuses, incentive payments and share options or other share awards;
  • ensure that contractual terms on termination and any payments made are fair to the individual and the Company; that failure is not rewarded and the duty to mitigate loss is fully recognised; oversee any major changes in employee benefits structures throughout the Company or Group; and agree the policy for authorising claims for expenses from the directors;
  • be responsible for establishing the selection criteria, selecting, appointing and setting the terms of reference for any remuneration of consultants who advise the Committee;
  • obtain reliable, up-to-date information about remuneration in other companies of comparable scale. The Committee shall have full authority to appoint remuneration consultants and to commission or purchase any reports, surveys or information which it deems necessary to help it fulfil its obligations within any budgetary restraints imposed by the board;
  • consider such other matters as may be requested by the board of directors; and
  • work and liaise as necessary with all other board committees.

Members

The Remuneration Committee comprises the following independent Non-Executive Directors:

Name Position Date
of
appointment
to
Committee
John Treacy Chair 14 May 2021
Prof. Dawn Coverley * Member 14 May 2021

*Prof. Dawn Coverley ceased to be a member of the Remuneration Committee on 1 January 2025.

Remuneration Components

The Company remunerates directors in line with best market practice in the industry in which it operates. As the Group is currently a pre-revenue business the components of Director's Remuneration consists of:

  • Base salaries
  • Pension benefits
  • Share incentive arrangements

These remuneration components will be reviewed at least annually by the Committee.

It is anticipated that once the Group becomes a revenue generating business that the following components of Directors Remuneration are likely to be appropriate:

  • Other benefits
  • Annual bonus

Directors' Remuneration Report for the year ended 31 December 2024 (cont'd)

Recruitment policy

Base salaries take into account market data for the relevant role, internal relativities, their individual experience and their current base salary. Where an individual is recruited at below market rates of remuneration, they may be re-aligned over a period of time, subject to their performance in their role.

Service Agreements and Letters of Appointment

The Executive Directors' service agreements are summarised below:

Executive
Director
Date of service
agreement
Initial term Notice
period
by
Company (Months)
Notice
period
by
Director (Months)
Allan Syms 14 May 2021 6 months 6 6
Nigel Lee 14 May 2021 N/a 6 6
Post year end
Dawn Coverley 1 January 2025 N/a 6 6

The Non-Executive Directors' service agreements are summarised below:

Non-Executive
Director
Date of service
agreement
Initial term Notice
period
by
Company (Months)
Notice
period
by
Director (Months)
John Treacy 14 May 2021 3 years 3 3
Dawn Coverley 14 May 2021 3 years 3 3

Non-Executive directors are typically expected to serve two three-year terms but may be invited by the Board to serve for an additional period. Any term renewal is subject to Board review and AGM re-election.

Remuneration of Executive Directors (audited)

The remuneration of the Executive Directors for the year ended 31 December 2024 was as follows:

Year ended 31 December 2024 Year ended 31 December 2023
Executive
Director
Basic salary Pension Total Basic salary Pension Total
£'000 £'000 £'000 £'000 £'000 £'000
Allan Syms 90 3 93 90 3 93
Nigel Lee 36 1 37 36 1 37
TOTAL 126 4 130 126 4 130

Directors' Remuneration Report for the year ended 31 December 2024 (cont'd)

Share scheme interests of executive directors (audited)

Executive
Director
Type of
scheme
Share
options at
31 Dec
2023
Granted
during the
year
Share options at
31 Dec 2024
Date from
which
exercisable
Expiry date
Allan
Syms
CSOP 23 8,868,096 - 8,868,096 **** 28 Jun 2033
CSOP 21 5,068,956 - 5,068,956 ** 2 Nov 2031
Nigel Lee
*
CSOP 23 6,224,233 - 6,224,233 **** 28 Jun 2033
CSOP 21 2,000,000 - 2,000,000 ** 2 Nov 2031
CSOP 17 500 - 500 9 Nov 2018 *** 8 Nov 2027
CSOP 16 800 - 800 27 Oct 2017 *** 26 Oct 2026
CSOP 15 300 - 300 25 May 2016 **** 25 Aug 2025
TOTAL 22,162,885 - 22,162,885

The interests of the executive directors in share schemes are shown in the table below:

* Includes brought forward 1,600 beneficial interests in share options as director of CFO Solutions Limited.

** subject to achievement of certain Group objectives.

*** One-third of the total options vest on first, second and third anniversary from date of grant.

**** One third of the options vest on 25 May 2016, 25 February 2017 and 25 August 2017.

**** Granted in respect of salary freeze for 2 years to 3 March 2025 – 50% exercisable on both 3 March 2024 and 3 March 2025.

In addition to this Nigel Lee had a beneficial interest in 18,571 shares of the Company that are held by CFO Solutions, a company that he is both a director and a shareholder. The have been no changes to this shareholding since 31 December 2024.

Remuneration of Non-Executive Directors (audited)

The remuneration of the Non-Executive Directors for the year ended 31 December 2024 was as follows:

Year ended 31 December 2024 Year ended 31 December 2023
Non
Executive
Basic
salary
Bonus Fees Pension Total Basic
salary
Bonus Fees Pension Total
Director £'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000
John
Treacy
30 - - - 30 30 - - - 30
Dawn
Coverley
40 - - 1 41 40 - - 1 41
TOTAL 70 - - 1 71 70 - - 1 71

Directors' Remuneration Report for the year ended 31 December 2024 (cont'd)

Share scheme interests of non- executive directors (audited)

Non
executive
Director
Type of
scheme
Share options
at 31 Dec
2023
Granted
during the
year
Exercised
in year
Share options
at 31 Dec
2024
Date from
which
exercisable
Expiry date
Dawn
Coverley
CSOP 23 7,614,540 - - 7,614,540 ** 28 Jun 2033
*** CSOP 21 12,672,389 - - 12,672,389 * 2 Nov 2031
John
Treacy
CSOP 23 6,235,629 - - 6,235,629 ** 28 Jun 2033
TOTAL 26,522,558 - - 26,522,558

The interests of the Non-Executive directors in share schemes are shown in the table below:

* subject to achievement of certain Group objectives.

** Granted in respect of salary freeze for 2 years to 3 March 2025 – 50% exercisable on both 3 March 2024 and 3 March 2025.

*** Note that Dawn Coverley became an executive director on 1 January 2025.

In addition to this Dawn Coverley owns 9,992,589 shares of the Company at 31 December 2024 and also has a beneficial interest in 7,055,548 shares of the Company that are held by her husband, Dr Justin Ainscough. There have been no changes to these shareholdings since 31 December 2024.

On 21 March 2025, Matt Bower, became a non-executive director of the Company and had previously been providing consultancy services through his service company, Makabo Limited. At 31 December 2024 Makabo Limited held 2,464,625 options over shares in the Company with an exercise price of 1.622965. These options were exercisable on the condition that VWAP of the Company's Ordinary shares is at least 3.24593p , being at least twice the Options grant price, from 25 May 2025 to 24 June 2025. These options will lapse on 25 June 2027.

Review of remuneration for all directors

On 7 March 2023 the Company announced director salary waivers and the award of share options. In conducting a review of director remuneration, the Company's remuneration committee was of the view that the Company's directors' salaries are currently below market comparables. However, even in a period of high inflation, the directors remain fully committed to maintaining low overheads and maximising the funds available to the Group for the development of its CIZ1B early lung cancer test. The directors have therefore agreed to waive any increase in basic salary for a period of two years from 3 March 2023 (which has now ended). In compensation, and subject to shareholder approval at the next Annual General Meeting of the Company, the Company has conditionally granted share options over new ordinary shares in the Company (the "Options") to the directors, with an exercise price equivalent to the volume weighted average price of the Company's ordinary shares for the month of February 2023 at 2.19376p per share. 50% of the Options will vest and become exercisable after the 12-month anniversary of grant; the remaining 50% shall vest and become exercisable on the 24-month anniversary of grant. The Options will have a 10 year life from the date of grant and are subject to good and bad leaver provisions. The Options are unapproved for the purposes of the enterprise management incentive and have been granted outside of, and in addition to, grants made under the Company's existing share option schemes.

Relative importance of total remuneration

The table below illustrates total employee remuneration compared to distributions to shareholders and operational cash outflow, excluding proceeds from the issue of ordinary shares (before issue costs):

Distributions
to
shareholders
Total employee pay
(£'000)
Group Operational
cash outflow (£'000)
Year ended 31 December 2024 - 215 358

Operational cash outflow has been shown in the table above as cash flow monitoring and forecasting are an important consideration for the Remuneration Committee and Board of Directors when determining cash-based remuneration for directors and employees.

Directors' Remuneration Report for the year ended 31 December 2024 (cont'd)

Historical remuneration

The remuneration of the directors since 2019 is as follows:

2019 2020 * 2021 * 2022 *
£'000 Sal Pen Total Sal Pen Total % Sal Pen Total % Sal Bonus Pen Total %
Allan Syms 18 - 18 30 - 30 66% 70 1 71 136
%
90 - 3 93 31
%
Nigel Lee - - - - - - - 21 1 22 N/a 36 - 1 37 68
%
Dawn
Coverley
- - - - - - - 25 1 26 N/a 40 104 1 145 457%
John
Treacy
28 - 28 30 - 30 - 30 - 30 - 30 - - 30 -
Total 46 - 46 60 - 60 30% 146 3 149 148% 196 104 5 305 105%

*represents percentage change over the previous two years.

2023 * 2024 *
£'000 Sal Pen Total % Sal Pen Total %
Allan Syms 90 3 93 - 90 3 93 -
Nigel Lee 36 1 37 - 36 1 37 -
Dawn Coverley 40 1 41 (72%) 40 1 41 -
John Treacy 30 - 30 - 30 - 30 -
Total 196 5 204 (33%) 196 5 204 -

Pension Schemes

The Group and Company do not operate any defined benefit pension schemes. Any pension contributions are paid into defined contribution schemes of individual employees.

Directors' Remuneration Report for the year ended 31 December 2024 (cont'd)

Historical share price performance comparison

The table below compares the share price performance (based on notional investment of £100) of Cizzle Biotechnology Holdings PLC against the FTSE SmallCap and FTSE Techmark Mediscience based on prices/indices at close of business from 1 January 2024 to 31 December 2024. Note that month end prices are based on the last day of trading of each month. The FTSE SmallCap has been chosen to provide a wider market comparator and the FTSE Techmark Mediscience chosen due to sector relevance:

Consideration of shareholder views

The Board considers shareholder feedback received and guidance from shareholder bodies. This feedback is considered as part of the Company's policy on remuneration.

Approved on behalf of the Board of Directors

John Treacy Director and Chair of the Remuneration Committee

30 April 2025

INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF CIZZLE BIOTECHNOLOGY HOLDINGS PLC

Opinion

We have audited the financial statements of Cizzle Biotechnology Holdings Plc (the 'company') and its subsidiaries (the 'group') for the year ended 31 December 2024 which comprise the Consolidated Statement of Comprehensive Income, the Consolidated and Company Statements of Financial Position, the Consolidated and Company Statements of Changes in Equity, the Consolidated and Company Statements of Cash Flows and notes to the financial statements, including significant accounting policies. The financial reporting framework that has been applied in their preparation is applicable law and UKadopted international accounting standards and as regards the company financial statements, as applied in accordance with the provisions of the Companies Act 2006.

In our opinion:

  • the financial statements give a true and fair view of the state of the group's and of the company's affairs as at 31 December 2024 and of the group's loss for the year then ended;
  • the group financial statements have been properly prepared in accordance with UK-adopted international accounting standards;
  • the company financial statements have been properly prepared in accordance with UK-adopted international accounting standards and as applied in accordance with the provisions of the Companies Act 2006; and
  • the financial statements have been prepared in accordance with the requirements of the Companies Act 2006.

Basis for opinion

We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards are further described in the Auditor's responsibilities for the audit of the financial statements section of our report. We are independent of the group and company in accordance with the ethical requirements that are relevant to our audit of the financial statements in the UK, including the FRC's Ethical Standard as applied to listed public interest entities, and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.

Material uncertainty related to going concern

We draw attention to note 2.2 in the financial statements, which indicates that the group and company is reliant on the timely receipt of agreed royalty payments from a third party to be able to continue as a going concern for at least the 12 months from the date of these financial statements. There remains uncertainty if the third party will be able to make these payments as it is dependent on raising further funds. Should these royalty payments be delayed or not materialise, then the company may be required to raise additional funding to continue to meet its obligations. As stated in note 2.2, these events or conditions, along with the other matters as set forth in note 2.2, indicate that a material uncertainty exists that may cast significant doubt on the company's ability to continue as a going concern. Our opinion is not modified in respect of this matter.

In auditing the financial statements, we have concluded that the directors' use of the going concern basis of accounting in the preparation of the financial statements is appropriate. Our evaluation of the directors' assessment of the company's ability to continue to adopt the going concern basis of accounting included:

  • Testing the mathematical accuracy of the base case and a downside scenario forecasts;
  • Evaluating and challenging the appropriateness of the forecasting method by using our understanding of the group and company and by considering past historical accuracy of the directors' forecasting and comparing the actual post year end results with the forecasts;
  • Understanding the forecasts including the key inputs used and sources of these inputs through inquiries with the directors and management and, where possible, obtaining supporting documentation for such key inputs;
  • Performing sensitivity analysis on the main assumptions and considering if whether there is still sufficient cash on hand to cover their working capital;

INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF CIZZLE BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)

  • Reviewing the reasonableness of downside scenarios; and
  • Assessing the appropriateness and adequacy of the group's and company's going concern disclosures included in the financial statements.

Our responsibilities and the responsibilities of the directors with respect to going concern are described in the relevant sections of this report.

Our application of materiality

The scope of our audit was influenced by our application of materiality. We set certain quantitative thresholds for materiality. These, together with qualitative considerations, helped us to determine the scope of our audit and the nature, timing and extent of our audit procedures on the individual financial statement line items and disclosures and in evaluating the effect of misstatements, both individually and in aggregate on the financial statements as a whole. Based on our professional judgement, we determined the materiality thresholds for the financial statements as follows:

Group Financial Statements Company financial
statements
Material for the financial
statements as a whole
£16,300 (2023: £73,300) £12,800 (2023: £69,600)
Performance materiality £13,000 (2023: £51,300) £10,200 (2023: £48,700)
Basis for materiality for the
financial statements as a
whole
2% of the group's expenses (2023:
5% of the group's net assets)
2% of the company's expenses
(2023: 5% of the company's net
assets, capped at 95% of group
materiality)
Rationale The focus of the financial statement users is on the company's ability to
manage its operational expenses and maintain sufficient liquidity to
continue its research and development activities. Since the company
has not yet generated revenue, the primary financial metrics of interest
are the levels of expenses, the rate at which cash is being used, and
the efficiency of resource allocation. These metrics provide insights into
the company's operational sustainability and its progress towards
achieving commercial viability.
The percentage applied to the benchmark has been selected to bring
into scope all significant classes of transactions, account balances and
disclosures relevant for the members, and also to ensure that matters
that would have a significant impact on the results were appropriately
considered.
Performance materiality has been set at 80% of materiality for the
financial statements as a whole, for both the group and company. The
percentage applied was determined after considering the number and
quantum
of
identified
misstatements
in
the
prior
year
audit,
management's attitude to correcting misstatements identified and our
cumulative knowledge of the group and
company including the
environment they operate in.

INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF CIZZLE BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)

Our approach to the audit

In designing our audit approach, we determined materiality, as above, and assessed the risk of material misstatement in the financial statements. In particular, we looked at significant risk areas being the valuation of the investment held in subsidiary (Company only) and other income. As part of our work on going concern we considered future events that are inherently uncertain such as future research and development expenditure and the expected royalty payments to be received from the agreement entered into with third party.

We also addressed the risk of management override of internal controls, including evaluating whether there was evidence of bias by management that represented a risk of material misstatement due to fraud.

There are three components in the group being the company and two subsidiary undertakings, namely, Cizzle Biotechnology Limited and Cizzle Biotech Limited (dormant entity). Of the trading components, both were considered key based on size and containing the key audit risks identified during our planning and accordingly, a full scope audit was performed on both these components. Our audit was performed from our London office with regular contact with management and the directors throughout the audit. This, in conjunction with additional procedures performed, gave us sufficient and appropriate evidence for our opinion on the group and company financial statements.

Key audit matters

Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the financial statements of the current period and include the most significant assessed risks of material misstatement (whether or not due to fraud) we identified, including those which had the greatest effect on: the overall audit strategy, the allocation of resources in the audit; and directing the efforts of the engagement team. These matters were addressed in the context of our audit of the financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. In addition to the matter described in the Material uncertainty related to going concern section we have determined the matters described below to be the key audit matters to be communicated in our report.

INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF CIZZLE BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)

Key Audit Matter How our scope addressed this matter
Valuation of Investments (Company Only) –
Notes 2.6 and 11
The Company carries a material "Investment
in subsidiary undertakings" balance in its
Statement of Financial Position. There is a
risk that the carrying value of the
Investments is greater than the recoverable
amount and is therefore impaired.
As the estimated recoverable amount of
investments is subjective due to the inherent
uncertainty involved in ascertaining whether
any impairment indicators are met and if so,
forecasting and discounting future cashflows,
there is a risk that the carrying value of
investments are overstated.
Our work in this area included:

Considering the existence of impairment indicators
per IAS 36 Impairment of Assets, which included
but were not limited to considering the external
and internal sources of information. This included:
o
Reviewing key assumptions and inputs
made by management's expert in the
valuation of the subsidiary in previous years
and ascertaining whether there have been
any changes to the basis of these key
assumptions and inputs that would indicate
an impairment;
o
Reviewing and discussing the development
timelines of the Biomarker and the key
milestones that were estimated to be
reached since the acquisition of the
subsidiary;
o
Assessing the changes to the biotechnology
market and the technological and legal
environment and the implications to the
expected prices and costs included in the
valuation; and
o
Reviewing the progress of the underlying
research and development of the Biomarker
since the acquisition and assessing the
future plans of the group and company as
part of our going concern.

Reviewing the value of the net investment in
subsidiaries against the supporting underlying
assets;

Reviewing
the
associated
disclosures
in the
financial
statements
and
assessing
the
appropriateness of such disclosures.
Based on the procedures performed, we concluded that
Other Income (Group) Note 2.4 management's impairment assessment are reasonable.
During the year the Group signed its first
license agreement on which it recognised
income.
The agreement involves significant upfront
and milestone payments, as well as royalty
payments. There is a risk that the amounts
may be recognised prematurely, inaccurately
or not disclosed correctly as revenue in the
financial statements. Given that Cizzle has not
had any of such agreements in the past, there
is currently no accounting policy in place to
handle
the
accurate
recognition
of
the
amounts.
Our work in this area included:

Reviewing the terms of the agreement to ensure
revenue
is
recognised
in
accordance
with
applicable accounting standards (e.g., IFRS 15).

Verifying the timing and amounts of upfront and
milestone payments.

Confirming the accuracy of royalty calculations
and ensure they are based on net sales as
stipulated.

Reviewing the associated disclosures in the
financial
statements
and
assessing
the
appropriateness of such disclosures.
Based on the procedures performed, we concluded that
management's
income
recognition
assessment
is
reasonable.

INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF CIZZLE BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)

Other information

The other information comprises the information included in the annual report, other than the financial statements and our auditor's report thereon. The directors are responsible for the other information contained within the annual report. Our opinion on the group and company financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon. Our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the course of the audit, or otherwise appears to be materially misstated. If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether this gives rise to a material misstatement in the financial statements themselves. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact.

We have nothing to report in this regard.

Opinions on other matters prescribed by the Companies Act 2006

In our opinion the part of the directors' remuneration report to be audited has been properly prepared in accordance with the Companies Act 2006.

In our opinion, based on the work undertaken in the course of the audit:

  • the information given in the strategic report and the directors' report for the financial year for which the financial statements are prepared is consistent with the financial statements; and
  • the strategic report and the directors' report have been prepared in accordance with applicable legal requirements.

Matters on which we are required to report by exception

In the light of the knowledge and understanding of the group and the company and their environment obtained in the course of the audit, we have not identified material misstatements in the strategic report or the directors' report.

We have nothing to report in respect of the following matters in relation to which the Companies Act 2006 requires us to report to you if, in our opinion:

  • adequate accounting records have not been kept by the company, or returns adequate for our audit have not been received from branches not visited by us; or
  • the company financial statements and the part of the directors' remuneration report to be audited are not in agreement with the accounting records and returns; or
  • certain disclosures of directors' remuneration specified by law are not made; or
  • we have not received all the information and explanations we require for our audit.

Responsibilities of directors

As explained more fully in the statement of directors' responsibilities, the directors are responsible for the preparation of the group and company financial statements and for being satisfied that they give a true and fair view, and for such internal control as the directors determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the group and company financial statements, the directors are responsible for assessing the group's and the company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the group or the company or to cease operations, or have no realistic alternative but to do so.

Auditor's responsibilities for the audit of the financial statements

Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our

INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF CIZZLE BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)

opinion. Reasonable assurance is a high level of assurance but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.

Irregularities, including fraud, are instances of non-compliance with laws and regulations. We design procedures in line with our responsibilities, outlined above, to detect material misstatements in respect of irregularities, including fraud. The extent to which our procedures are capable of detecting irregularities, including fraud is detailed below:

  • We obtained an understanding of the group and company and the sector in which they operate to identify laws and regulations that could reasonably be expected to have a direct effect on the financial statements. We obtained our understanding in this regard through discussions with management, industry research, application of cumulative audit knowledge and experience of the biotechnology sector.
  • We determined the principal laws and regulations relevant to the group and company in this regard to be those arising from:
    • o Companies Act 2006;
    • o UK-adopted International Accounting Standards;
    • o Health and Safety Act 1974;
    • o Listing and Disclosure and Transparency Rules;
    • o LSE Main Market Listing Regulations;
    • o Anti-bribery and anti-money laundering regulations;
    • o QCA Code; and
    • o UK taxation law.
  • We designed our audit procedures to ensure the audit team considered whether there were any indications of non-compliance by the group and company with those laws and regulations.

These procedures included, but were not limited to:

  • o Holding discussions with management and the directors and considering whether there were any known or suspected instances of non-compliance with laws and regulations or fraud;
  • o Reviewing board meeting minutes;
  • o Reviewing Regulatory News Service (RNS) announcements; and
  • o Reviewing legal and regulatory correspondence and legal expenses.
  • We also identified the risks of material misstatement of the financial statements due to fraud. We considered, in addition to the non-rebuttable presumption of a risk of fraud arising from management override of controls, that the potential for management bias was identified in relation to the valuation of investments and income recognition (detailed in the key audit matters section of our report). We addressed this by challenging the assumptions and judgements made by management when auditing that significant accounting estimate and ensuring that there were adequate disclosures included in the respective notes.
  • As in all of our audits, we addressed the risk of fraud arising from management override of controls by performing audit procedures which included, but were not limited to: the testing of journals; reviewing accounting estimates for evidence of bias; and evaluating the business rationale of any significant transactions that are unusual or outside the normal course of business.

Because of the inherent limitations of an audit, there is a risk that we will not detect all irregularities, including those leading to a material misstatement in the financial statements or non-compliance with regulation. This risk increases the more that compliance with a law or regulation is removed from the events and transactions reflected in the financial statements, as we will be less likely to become aware of instances of non-compliance. The risk is also greater regarding irregularities occurring due to fraud rather than error, as fraud involves intentional concealment, forgery, collusion, omission or misrepresentation.

INDEPENDENT AUDITOR'S REPORT TO THE MEMBERS OF CIZZLE BIOTECHNOLOGY HOLDINGS PLC (CONTINUED)

A further description of our responsibilities for the audit of the financial statements is located on the Financial Reporting Council's website at: www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditor's report.

Other matters which we are required to address

We were appointed by the directors on 13 February 2019 to audit the financial statements for the period ending 31 December 2018 and subsequent financial periods. Our total uninterrupted period of engagement is 7 years, covering the periods ending 31 December 2018 to 31 December 2024.

The non-audit services prohibited by the FRC's Ethical Standard were not provided to the group or the company and we remain independent of the group and the company in conducting our audit.

Our audit opinion is consistent with the additional report to the audit committee.

Use of our report

This report is made solely to the company's members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state to the company's members those matters we are required to state to them in an auditor's report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone, other than the company and the company's members as a body, for our audit work, for this report, or for the opinions we have formed.

Hannes Verwey (Senior Statutory Auditor) 15 Westferry Circus For and on behalf of PKF Littlejohn LLP Canary Wharf Statutory Auditor London E14 4HD

30 April 2025

Consolidated Statement of Comprehensive Income for the year ended 31 December 2024

Group Group
Notes Year ended 31 Year ended 31
December December
2024 2023
£'000 £'000
Administrative expenses
-
on-going administrative costs
6 (687) (669)
-
cost associated with put option
6 - (120)
-
share option charge
6 (189) (307)
-
gain on transfer of intangible asset
6 - 44
-
net fair value loss on financial asset measured at
fair value through profit or loss
6 (1,391) (711)
Total administrative expenses (2,269) (1,763)
Other income 82 -
Operating loss and loss before income tax (2,187) (1,763)
Income tax 9 21 46
Loss and total comprehensive income for the year (2,166) (1,717)
attributable to the equity shareholders of the parent
Loss per ordinary share (pence) attributable to the
equity shareholders:
Continued operations basic and diluted 10 (0.6p) (0.5p)
Loss per ordinary share (pence) attributable to
the equity shareholders of the parent 10 (0.6p) (0.5p)

The above results relate entirely to continuing activities. The Company has elected to take the exemption provided under section 408, Companies Act 2006 from presenting the Company statement of comprehensive income.

Registered number: 06133765 (England and Wales)

Consolidated Statement of Financial Position As at 31 December 2024

Notes Group
2024
£'000
Group
2023
£'000
Non-current assets
Intangible asset 11 - -
- -
Current assets
Inventories 13 2 -
Investment held at fair value through profit or loss 12 22 1,413
Trade and other receivables 14 103 136
Cash and cash equivalents 15 365 144
492 1,693
Total assets 492 1,693
Equity
Capital and reserves attributable to equity holders
of the Company
Ordinary shares 16 3,507 3,504
Share premium 35,911 35,335
Reverse acquisition reserve (40,021) (40,021)
Share capital reduction reserve 10,081 10,081
Share option reserve 640 478
Retained losses (10,036) (7,870)
Total equity 82 1,507
Liabilities
Current liabilities
Trade and other payables 17 410 186
Total liabilities 410 186
Total equity and liabilities 492 1,693

The notes on pages 49 to 66 are an integral part of these financial statements.

The financial statements were approved and authorised for issue by the board on 30 April 2025 and were signed on its behalf by:

Nigel Lee Director

Registered number: 06133765 (England and Wales)

Company Statement of Financial Position As at 31 December 2024

Notes 2024
£'000
2023
£'000
Non-current assets
Intangible asset 11 - -
Investments 11 21,803 21,803
21,803 21,803
Current assets
Investment held at fair value through profit or loss 12 22 1,413
Trade and other receivables 14 990 830
Cash and cash equivalents 15 23 70
1,035 2,313
Total assets 22,838 24,116
Equity
Capital and reserves attributable to equity holders
of the company
Ordinary shares 16 3,507 3,504
Share premium 35,911 35,335
Share capital reduction reserve 10,081 10,081
Share option reserve 640 478
Accumulated losses (27,433) (25,407)
Total equity 22,706 23,991
Liabilities
Current liabilities
Trade and other payables 17 132 125
Total liabilities 132 125
Total equity and liabilities 22,838 24,116

The notes on pages 49 to 66 are an integral part of these financial statements. The loss for the year of the Company was £2,026,000 (2023: loss of £1,540,000).

The financial statements were approved and authorised for issue by the board on 30 April 2025 and were signed on its behalf by:

Nigel Lee Director

Consolidated Statement of Cash Flows for the year ended 31 December 2024

Notes Group
2024
Group
2023
£'000 £'000
Cash flows from operating activities
Operating (loss) before tax (2,188) (1,763)
Movement on put option - 120
Gain on transfer of intangible asset - (44)
Net fair value loss on financial assets measured at fair
value through profit or loss
1,391 711
Share option charge 162 307
Operating cash flow before working capital movements (635) (669)
Decrease in inventories 13 2 -
Decrease in trade and other receivables 14 6 (24)
Increase in trade and other payables 17 223 13
Cash used in operations (404) (680)
Tax received 46 41
Net cash used in operating activities (358) (639)
Cash flows from financing activities
Proceeds from the issue of ordinary shares (net of issue
costs) 16 579 305
Net cash generated from financing activities 579 305
Net increase / (decrease) in cash and cash equivalents 221 (334)
Cash and cash equivalents at the start of the year 15 144 478
Cash and cash equivalents at the end of the year 15 365 144

The notes on pages 49 to 66 are an integral part of these financial statements.

* For the year ended 31 December 2023, included in the movements in investing activities is a non-cash movements of £2,080,000 explained further in note 11 and 12 related to the transfer of the intangible assets to the investment in Conduit Pharmaceuticals Limited.

Company Statement of Cash Flows for the year ended 31 December 2024

Notes 2024 2023
£'000 £'000
Cash flows from operating activities
Loss before tax (2,026) (1,540)
Share option charge
Movement on put option
162 307
Gain on transfer of intangible asset -
-
120
(44)
Net fair value loss on financial assets measured at fair
value through profit or loss
1,391 711
Operating cash flow before working capital movements (473) (446)
Change in trade and other receivables 14 2 (14)
Change in trade and other payables 17 7 (27)
Net cash used in operating activities (464) (487)
Cash flows from investing activities
Change in intra group funding (162) (212)
Net cash used in investing activities (162) (212)
Cash flows from financing activities
Proceeds from the issue of ordinary shares (net of issue
costs) 16 579 305
Net cash generated from financing activities 579 305
Net (decrease) in cash and cash equivalents (47) (394)
Cash and cash equivalents at the start of the year 15 70 464
Cash and cash equivalents at the end of the year 15 23 70

Consolidated statement of Changes in Equity for the year ended 31 December 2024

Group Ordinary
Share
Capital
Share
Premium
Shares
to be
issued
Capital
Redemption
Reserve
Share
Option
Reserve
Reverse
Acquisition
Reserve
Retained
Losses
Total
£'000 £'000 £'000 £'000 £'000 £'000 £'000 £'000
At 1 January 2023 3,502 34,917 115 10,081 199 (40,021) (6,153) 2,640
Registration of shares to be issued - 115 (115) - - - - -
Issue of shares for cash 2 348 - - - - - 350
Costs of share issue - (45) - - - - - (45)
Share option charge - - - - 279 - - 279
3,504 35,335 - 10,081 478 (40,021) (6,153) 3,224
Comprehensive Loss for the year - - - - - - (1,717) (1,717)
At 31 December 2023 3,504 35,335 - 10,081 478 (40,021) (7,870) 1,507
Issue of shares for cash 3 648 - - - - - 651
Costs of share issue - (72) - - - - - (72)
Share option charge - - - - 162 - - 162
3,507 35,911 - 10,081 640 (40,021) (7,870) 2,248
Comprehensive Loss for the year - - - - - - (2,166) (2,166)
At 31 December 2024 3,507 35,911 - 10,081 640 (40,021) (10,036) 82

Company statement of Changes in Equity for the year ended 31 December 2024

Ordinary
Share
Capital
£'000
Share
premium
£'000
Shares
to be
issued
£'000
Share capital
reduction
reserve
£'000
Share
option
reserve
£'000
Retained
Losses
£'000
Total
£'000
At 1 January 2023 3,502 34,917 115 10,081 199 (23,867) 24,947
Registration of shares to be issued - 115 (115) - - - -
Issue of shares cash 2 348 - - - - 350
Costs of share issue - (45) - - - - (45)
Share option charge for year - - - - 279 - 279
3,504 35,335 - 10,081 478 (23,867) 25,531
Comprehensive Loss for the year - - - - - (1,540) (1,540)
At 31 December 2023 3,504 35,335 - 10,081 478 (25,407) 23,991
Issue of shares cash 3 648 - - - - 651
Costs of share issue - (72) - - - - (72)
Share option charge for year - - - - 162 - 162
3,507 35,911 - 10,081 640 (25,407) 24,732
Comprehensive Loss for the year - - - - - (2,026) (2,026)
At 31 December 2024 3,507 35,911 - 10,081 640 (27,433) 22,706

Notes to the financial statements for the year ended 31 December 2024

1 General information

Cizzle Biotechnology Holdings PLC ("the Company" of "the Group") is a public limited company with its shares traded on the Main Market of the London Stock Exchange. On 14 May 2021 the Company acquired through a share for share exchange the entire share capital of Cizzle Biotechnology Limited. The Company is a holding company of a group of companies ("the Group") whose principal activity is the early detection of lung cancer via the development of an immunoassay test for the CIZ1B biomarker.

The directors consider there to be no ultimate controlling shareholder of the Company.

The address of the registered office is 6th Floor, 60 Gracechurch Street, London, EC3V 0HR and the registered number of the Company is 06133765.

2 Accounting policies

The principal accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.

2.1 Basis of preparation

The financial statements of Cizzle Biotechnology Holdings PLC ("the Company") including subsidiary undertakings (together referred to as "the Group") have been prepared in accordance with UK-adopted international accounting standards and the Companies Act 2006 on a historical cost basis. All figures have been rounded to the nearest £'000.

The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the Company's accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements are disclosed in Note 5.

The results for the year ended 31 December 2024 are the Group results.

(a) New standards and interpretations

The IASB and IFRS Interpretations Committee have issued the following standards and interpretations with an effective date of implementation of 1 January 2024.

i) New standards and amendments – applicable 1 January 2024

The following standard and interpretations apply for the first time to financial reporting periods commencing on or after 1 January 2024:

Effective for accounting
periods beginning on or after
Impact
Amendments to IAS 1: Presentation of Financial Statements:
Classification of Liabilities as Current or Non-current
1 January 2024 None
Amendments to IAS 1: Classification of Liabilities as Current
or Non-current - Deferral of Effective Date
1 January 2024 None
Amendments to IFRS 16 Leases: Lease Liability in a Sale
and Leaseback
1 January 2024 None
Amendments to IAS 1 Presentation of Financial Statements:
Non-current Liabilities with Covenants
1 January 2024 None
Amendments to IAS 7 Statement of Cash Flows and IFRS 7
Financial Instruments: Disclosures: Supplier Finance
Arrangements
1 January 2024 None

Notes to the financial statements for the year ended 31 December 2024

2 Accounting policies (continued)

ii) Forthcoming requirements

As at 31 December 2024, the following standards and interpretations had been issued but were not mandatory for annual reporting periods ending on 31 December 2024 and not early adopted.

Effective for accounting periods Impact
beginning on or after
Amendments to IAS 21 The Effects of Changes in 1 January 2025 None
Foreign Exchange Rate: Lack of Exchangeability
Amendments to IFRS 9 Financial Instruments and IFRS 1 January 2026 None
7 Financial Instruments: Disclosures: Classification and
Measurement of Financial Instruments
Annual Improvements to IFRS standards - Volume 11 1 January 2026 None

2.2 Going concern

Current funding

The Group's cash balance as at 31 December 2024 was £365,000 and there were no borrowing facilities at that date. On 26 March 2024 the Group announced that it has undertaken a conditional placing of 31,050,000 new ordinary shares of 0.01p each ("Ordinary Shares") in the Company (the "Placing") at a price of 2 pence per share (the "Issue Price") raising approximately £0.62 million before expenses for the Company. The net proceeds of the Placing will be utilised towards completing the Company's first proposed commercial test to detect CIZ1B, further protect the Company's Intellectual Property (IP), progress the Company's research with the University of York and for general corporate purposes.

The Directors have adopted the going concern basis in preparing the financial statements for the year ended 31 December 2024. In reaching this conclusion, the Directors have considered current trading and the current and projected funding position for approximately 20 months from the date of approval of the financial statements through to 31 December 2026. The forecasts have been prepared using a number of scenarios – a base case assumes receipt of minimum royalty payments and an 'Accelerated Growth' model assumes that revenues will be earned from royalties in Europe and the Rest of the World, more investment into research and development activities and expanding the UK team.

These scenarios show that the Group is reliant upon the timely receipt of the first \$1m (approx. £570,000) of Guaranteed Minimum Royalty Payments (GMP) from Cizzle Bio Inc ("Bio"), in respect of the Group's Royalty Agreement covering North America and The Caribbean. The receipt of two GMP instalments of \$250,000 (approx. £190k) in July and September 2025 is dependent on Bio signing a deal with a Caribbean hospital (recently signed) and would represent an advance of the first \$1m with the balance of a further receipt of GMP of \$500k (approx. £380k) is expected to be received in January 2026.The receipt of these royalties is not dependent upon Bio's appointed Research Laboratory, iGenomeDX, achieving a CLIA accreditation. However, there remains uncertainty if Bio will be able to make these payments as it is dependent on raising further funds. Should these royalty payments be delayed or not materialise, then the company may be required to raise additional funding to continue to meet its obligations.

Conclusion

After taking into account these conditions, it indicates that a material uncertainty exists that may cast significant doubt on the group and company's ability to continue as a going concern. These financial statements do not include any adjustments that would result from the going concern basis of preparation being inappropriate.

Notes to the financial statements for the year ended 31 December 2024

2 Accounting policies (continued)

2.3 Segmental reporting

IFRS 8 requires that segmental information be disclosed on the basis of information reported to the chief operating decision maker. The Company considers that the role of chief operating decision maker is performed by the Company's Board of Directors. The Group's only business activity and single segment is the development of tests for the early detection of lung cancer.

2.4 Revenue Recognition

Revenue is recognised in accordance with IFRS 15 – Revenue from Contracts with Customers, which establishes a five-step model to determine the timing and amount of revenue to be recognised. The core principle is that revenue is recognised to reflect the transfer of promised goods or services to customers in an amount that reflects the consideration the entity expects to receive in exchange.

The five steps applied to revenue recognition are:

    1. Identify the contract with a customer
  • A contract is an agreement between two or more parties that creates enforceable rights and obligations. 2. Identify the performance obligations in the contract
  • A performance obligation is a promise to transfer a distinct good or service to the customer.
    1. Determine the transaction price The transaction price is the amount of consideration the company expects to be entitled to in exchange for transferring promised goods or services.
    1. Allocate the transaction price to the performance obligations The transaction price is allocated to each performance obligation based on relative standalone selling prices.
    1. Recognise revenue when (or as) the entity satisfies a performance obligation Revenue is recognised when control of the good or service is transferred to the customer, either at a point in time or over time.

Royalty Income

For royalty income arising from licensing intellectual property, revenue is recognised according to the nature of the license granted:

  • Right to use (static license): Revenue is recognised at a point in time when the customer can begin using the IP.
  • Right to access (dynamic license): Revenue is recognised over time as the customer benefits from access to the IP throughout the license period.

If royalties are usage- or sales-based, revenue is recognised only when (or as) the subsequent sales or usage occurs, in accordance with the sales- or usage-based royalty exception in IFRS 15. B63–B63B.

Other income

Other income comprises an exclusivity fee in relation to a royalty agreement which is recognised on an accruals basis.

2.5 Foreign currency translation

The functional currency of the Company and its subsidiaries is Sterling which is also the presentational currency of the financial statements. Foreign currency assets and liabilities are converted into Sterling at the rates of exchange ruling at the end of the financial year. Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in the statement of comprehensive income.

2.6 Non-Current assets

Investments in intangible assets and subsidiaries are stated at cost less accumulated impairment.

Notes to the financial statements for the year ended 31 December 2024

2 Accounting policies (continued)

2.7 Investments classified as current assets

Assets that do not meet the criteria for amortised cost or fair value through other comprehensive income ("FVOCI") are measured at fair value through profit or loss ("FVPL"). A gain or loss on a debt investment that is subsequently measured at FVPL is recognised in profit or loss and presented net within other gains / (losses) in the period in which it arises.

2.8 Cash and cash equivalents

Cash and cash equivalents include cash in hand, deposits held at call with banks and other short-term highly liquid investments, with original maturities of three months or less.

2.9 Inventories

Raw materials, work in progress and finished goods are stated at the lower of cost and net realisable value on a 'first in first out' basis. Cost comprises of direct materials and delivery costs, direct labour, import duties and other taxes, an appropriate proportion of variable and fixed overhead expenditure based on normal operating capacity, and, where applicable, transfers from cash flow hedging reserves in equity. Costs of purchased inventory are determined after deducting rebates and discounts received or receivable.

Stock in transit is stated at the lower of cost and net realisable value. Cost comprises of purchase and delivery costs, net of rebates and discounts received or receivable.Net realisable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and the estimated costs necessary to make the sale.

2.10 Share capital

Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds. Note 23 describes all equity categories in further detail.

2.11 Current and deferred income tax

Current income tax is calculated on the basis of the tax laws enacted or substantively enacted at the statement of financial position date in the countries where the Company's subsidiaries and associates operate and generate taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation and establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities. Research and Development tax credits are accounted for on an accruals basis.

Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the financial statements. However, deferred income tax is not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit nor loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantively enacted by the statement of financial position date and are expected to apply when the related deferred income tax asset is realised or the deferred income tax liability is settled. Deferred income tax assets are recognised to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilised.

2.12 Share based payments

The Company operates an equity-settled, share-based compensation plan. The fair value of the employee services received in exchange for the grant of the options is recognised as an expense and credited to the share option reserve within equity. The total amount to be expensed over the vesting period is determined by reference to the fair value of the options granted, excluding the impact of any non-market vesting conditions (for example, profitability and sales growth targets). Options that lapse before vesting are credited back to income. The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and, if applicable, share premium when the options are exercised.

Notes to the financial statements for the year ended 31 December 2024

2.13 Financial instruments

i) Financial assets

The Company classifies its financial assets in the following measurement categories:

  • those to be measured subsequently at fair value through profit or loss; and
  • those to be measured at amortised cost.

The classification depends on the business model for managing the financial assets and the contracted terms of the cash flows. Financial assets are classified as at amortised cost only if both of the following criteria are met:

  • the asset is held within a business model whose objective is to collect contracted cash flows; and
  • the contractual terms give rise to cash flows that are solely payments of principal and interest.

Financial assets, including trade and other receivables and cash and bank balances, are initially recognised at transaction price, unless the arrangement constitutes a financing transaction, where the transaction is measured at the present value of the future receipts discounted at a market rate of interest. Such assets are subsequently carried at amortised cost using the effective interest method. At the end of each reporting period financial assets measured at amortised cost are assessed for objective evidence of impairment. If an asset is impaired the impairment loss is the difference between the carrying amount and the present value of the estimated cash flows discounted at the asset's original effective interest rate. The impairment loss is recognised in the consolidated income statement. The Company applies the simplified approach in calculating the expected credit losses (ECLs) as permitted by IFRS 9. Changes in credit risk is not tracked but instead a loss allowance is recognised at each reporting date based on the financial asset's lifetime ECL.

If there is a decrease in the impairment loss arising from an event occurring after the impairment was recognised the impairment is reversed. The reversal is such that the current carrying amount does not exceed what the carrying amount would have been had the impairment not previously been recognised. The impairment reversal is recognised in the consolidated income statement.

Financial assets are derecognised when (a) the contractual rights to the cash flows from the asset expire or are settled, or (b) substantially all the risks and rewards of the ownership of the asset are transferred to another party or (c) despite having retained some significant risks and rewards of ownership, control of the asset has been transferred to another party who has the practical ability to unilaterally sell the asset to an unrelated third party without imposing additional restrictions

ii) Financial liabilities

Basic financial liabilities, being trade and other payables, are initially recognised at transaction price, unless the arrangement constitutes a financing transaction, where the debt instrument is measured at the present value of the future receipts discounted at a market rate of interest. Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business from suppliers. Accounts payable are classified as current liabilities if payment is due within one year or less. If not, they are presented as non-current liabilities. Trade payables are recognised initially at transaction price and subsequently measured at amortised cost using the effective interest method.

Financial liabilities are derecognised when the liability is extinguished, that is when the contractual obligation is discharged, cancelled or expires. The Company does not hold or issue derivative financial instruments.

Notes to the financial statements for the year ended 31 December 2024

2.13 Financial instruments (continued)

iii) Offsetting

Financial assets and liabilities are offset and the net amounts presented in the financial statements when there is an enforceable right to set off the recognised amounts and there is an intention to settle on a net basis or to realise the asset and settle to liability simultaneously.

2.14 Pensions

For defined contribution schemes the amount charged to the statement of comprehensive income is the contribution payable in the year. Differences between the contributions payable in the year and contributions actually paid are shown either as accruals or prepayments.

3 Reverse acquisition

On 14 May 2021 the Company acquired through a share for share exchange the entire share capital of CBL whose principal activity is the early detection of lung cancer through the development of tests to detect CIZ1B variant protein.

Although the transaction resulted in CBL becoming a wholly owned subsidiary of the Company, the transaction constitutes a reverse acquisition as the previous shareholders of CBL own a substantial majority of the shares of the Company.

In substance the shareholders of CBL acquired a controlling interest in the Company and the transaction has therefore been accounted for as a reverse acquisition. As the Company's activities prior to the acquisition were purely the maintenance of the AIM listing, acquiring CBL and raising equity finance to provide the required funding for the operations of the acquisition means it did not meet the definition of a business combination in accordance with IFRS 3.

Accordingly, this reverse acquisition does not constitute a business combination and was accounted for in accordance with IFRS 2 "Share-based Payments" and associated IFRIC guidance. Although the reverse acquisition is not a business combination, the Company has become a legal parent and is required to apply IFRS 10 and prepare consolidated financial statements. The directors have prepared these financial statements using the reverse acquisition methodology, but rather than recognise goodwill, the difference between the equity value given up by the CBL shareholders is charged to the statement of comprehensive income as a share-based payment on reverse acquisition, and represents in substance the cost of acquiring a quoted company.

In accordance with the reverse acquisition principles, these consolidated financial statements represent a continuation of the consolidated statements of Cizzle Biotechnology Holdings Plc and its subsidiaries and include: - The assets and liabilities of CBL at their pre-acquisition carrying value amounts and the results for all periods reported; and

  • The assets and liabilities of the Company as at 14 May 2021 and its results from the date of reverse acquisition (14 May 2021 to 31 December 2021).

On 14 May 2021 the Company issued 206,310,903 ordinary shares to acquire the 313,932 ordinary shares of CBL Limited. At 14 May 2021 the valuation of the investment in CBL was £21,700,000.

Because the legal subsidiary, CBL, was treated on consolidation as the accounting acquirer and the legal parent company, Cizzle Biotechnology Holdings Plc, was treated as an accounting subsidiary, the fair value of the shares deemed to be issued by CBL was calculated at £2,587,000 based on an assessment of the purchase consideration for a 100% holding of Cizzle Biotechnology Holdings plc.

The fair value of the net liabilities of Cizzle Biotechnology Holdings Plc at acquisition was as follows:

£'000
Cash and cash equivalents 46
Other assets 47
Liabilities (310)
Net (Liabilities) (217)

Notes to the financial statements for the year ended 31 December 2024

3 Reverse acquisition (continued)

The difference between the deemed cost of £2,587,000 and the fair value of the net liabilities noted above of £(217,000) resulted in £2,804,000 being expensed as "reverse acquisition expenses" in accordance with IFRS2, Share- based Payments, reflecting the economic cost to CBL shareholders of acquiring a quoted entity.

The reverse acquisition reserve which arose from the reverse takeover is made up as follows:

£'000
Pre-acquisition equity1 (22,621)
CBL share capital at acquisition2 1,599
Investment in CBL3 (21,803)
Reverse acquisition expense4 2,804
(40,021)
    1. Pre-acquisition equity of Cizzle Biotechnology Holdings PLC at 14 May 2021.
    1. CBL had issued share capital and share premium of £1,599,000. As these financial statements represent the capital structure of the legal parent entity, the equity of CBL is eliminated.
    1. The value of the shares issued by the Company in exchange for the entire share capital of CBL plus stamp duty expenses.
    1. The reverse acquisition expense represents the difference between the value of the equity issued by the Company, and the deemed consideration given by CBL to the Group.

4 Financial risk

The Group's principal risk factors are as follows:

4.1 Capital risk management

The Company monitors capital which comprises all components of equity (i.e. share capital, share premium, capital reduction reserve, share option reserve, and retained earnings/losses). Note 22 describes how capital is managed in respect of the debt to equity ratio.

4.2 Financial risk factors

The Group's operations exposed it to a variety of financial risks that had included the effects of Level One investment risk, credit risk, liquidity risk and interest rate risk. The Company had in place a risk management programme that attempted to limit the adverse effects on the financial performance of the Company by monitoring levels of debt finance and the related finance costs. The Company did not use derivative financial instruments to manage interest rate costs and as such, no hedge accounting was applied.

Given the size of the Company, the directors did not delegate the responsibility of monitoring financial risk management to a sub-committee of the Board. The policies set by the board of directors were implemented by the Company's finance department.

(a) Credit risk

The Company's credit risk was primarily attributable to its trade receivables balance. The amounts presented in the statement of financial position are net of allowances for impairment. The credit risk on the current asset investment arises from the investment in a Nasdaq quoted company. The Group reviews the market price of this investment on a daily basis.

(b) Liquidity risk

Liquidity risk is the risk that an entity will encounter difficulty in meeting obligations associated with financial liabilities. The Company's financial liabilities included its trade and other payables shown in Note 17. The Group manages this risk through the preparation of cash flow forecasts which are regularly reviewed by the directors.

Notes to the financial statements for the year ended 31 December 2024

5 Critical accounting estimates and judgements

In the preparation of the financial statements the directors must make estimates and assumptions that affect the asset and liability items and revenue and expense amounts recorded in the financial statements. These estimates are based on historical experience and various other assumptions that the Board believes are reasonable under the circumstances. The results of this form the basis for making judgements about the carrying value of assets and liabilities that are not readily available from other sources.

a) Accounting judgement

The Company's principal judgement in 2024 relate to its impairment review of its investment in its subsidiary company, CBL. Following the review of these assets at 31 December 2024 the directors considered that there was no indication of impairment loss is required to be made. The main indicators that no impairment loss arises are the receipt of royalties from Bio in relation to North America, the extension of the royalty agreement with Bio to cover The Caribbean and also the recent announcement that Bio has signed its first contract with a hospital in the Caribbean.

b) Accounting estimate

Share based payments

See Note 15 which explains the methods used to estimate the fair value of share options granted.

6 Operating expenses

Group Group
2024 2023
£'000 £'000
Research and development 213 214
Professional advisers 139 173
Staff costs 143 146
Intellectual property renewal fees 22 22
Regulatory fees 36 13
Audit fees (Note 7) 41 36
Other expenditure 95 65
On-going administrative costs 689 669
Share option charge 189 307
Cost associated with put option - 120
Gain on transfer of intangible asset - (44)
Net fair value loss on financial asset measured at fair
value through profit or loss 1,391 711
Total administrative expenses 2,269 1,763

7 Auditor's remuneration

Group Group
2024 2023
£'000 £'000
Fees payable to the Company's auditor for the audit of the Group,
Company and subsidiary financial statements
41 36
41 36

8 Directors' emoluments

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Wages and salaries 196 196 124 133
Social Security Costs 14 22 14 15
Pension Contributions 5 5 5 3
Share based payments* 186 307 186 307
401 530 329 458

Notes to the financial statements for the year ended 31 December 2024

8. Directors' emoluments (continued)

*Included in the share based payment charge is £27,000 (2023:£28,000) related to the employee contribution of the national insurance which has been accrued for as the Company has taken on the obligation on the employee's behalf.

The Group does not have any employees other than the directors. The average number of directors during the year was 4 (2023: 4).

9 Income tax credit

The tax credit for the year was as follows:

Group Group
2024 2023
£'000 £'000
Research and development tax credits
-
Current year
(30) (47)
-
Prior year
9 1
(21) (46)

Research and Development tax credits are accounted for on an accruals basis.

The tax on the Group's loss before tax differs from the theoretical amount that would arise using the tax rate applicable to the losses of the Group as follows:

Group Group
2024 2023
£'000 £'000
Loss before tax on continuing operations (2,187) (1,763)
Tax calculated at the domestic rate applicable of 19%* (2023: 19%) (416) (335)
Expenses not deductible for tax purposes 306 209
Tax losses for which no deferred tax credit was recognised 110 126
Research and development tax credit (22) (46)
Total income tax credit (22) (46)

*19% has been used as the Company generates profits of less than £50k

10 Loss per share

Basic loss per share

Group Group
2024 2023
Loss for the year (2,166,000) (1,717,000)
Weighted average number of ordinary shares 387,473,965 355,861,445
Basic loss per share (0.6p) (0.5p)

The basic loss per share is derived by dividing the loss for the period attributable to ordinary shareholders by the weighted average number of shares in issue.

Diluted earnings per share is calculated by dividing the loss attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding after adjusting these amounts for the effects of dilutive potential ordinary shares. As the results for the years ended 31 December 2024 and 31 December 2023 are a loss, any exercise of share options would have an anti-dilutive effect on earnings per share. Consequently, earnings per share and diluted earnings per share are the same and the calculation has not been included.

As at 31 December 2024, there were share options over 48,685,443 shares (2023: 48,685,443 shares), which could potentially have a dilutive impact in the future. In addition to this Makabo Limited , a service company operated by Matt Bower who was appointed as a non-executive director on 21 March 2025, had 2,464,625 options outstanding (2023: Nil).

Notes to the financial statements for the year ended 31 December 2024

11 Non- Current assets

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Investment in subsidiary undertakings - - 21,803 21,803
Intangible assets - - - -
Total investments - - 21,803 21,803

a. Investments in subsidiary undertakings - Company

2024 2023
£'000 £'000
Opening balance 21,803 21,803
Acquisition during the year - -
Closing balance 21,803 21,803

The investment in subsidiary undertakings is in the following companies:

Name Country of
incorporation
Proportion of ownership
interest
Principal activities/status
Cizzle Biotechnology England and 100% interest in ordinary share Early detection of lung
Limited Wales capital cancer
Cizzle Biotech Limited England and 100% interest in ordinary share Dormant
(formerly Enfis Limited) Wales capital

The registered address for ongoing subsidiaries is 6th floor, 60 Gracechurch Street, London, EC3V 0HR. Cizzle Biotechnology Limited - as mentioned in Note 3, this investment represents the value of the shares issued by the Company in exchange for the entire share capital of CBL (£21,700,000 plus stamp duty expenses of £103,000).

b. Intangible assets – Group and Company

2024
£'000
2023
£'000
Opening balance - 2,080
Acquisition during the year - -
Disposal (traded for investment measured at - (2,080)
fair value through profit or loss)*
Closing balance - -

* During 2023 the Company exercised a put option which meant that the intangible asset was traded for an investment in Conduit Pharmaceuticals Limited ("Conduit") as set out in Note 12 resulting in a gain of £44,000.

On 14 February 2022, the Company entered into a definitive agreement (the "Agreement") with Conduit and St George Street Capital Limited ("SGSC") to acquire a 5% economic interest in the commercialisation of the AZD 1656 asset or other such assets being developed by Conduit or SGSC to treat inflammatory pulmonary and cardiovascular disease (the "Economic Interest").

Notes to the financial statements for the year ended 31 December 2024

11 Non- Current assets (continued)

b. Intangible assets – Group and Company (continued)

Highlights of the Agreement are as follows:

  • Agreement with Conduit and SGSC to acquire a 5% economic interest for a total consideration of £1.88 million, to be settled in new Cizzle ordinary shares at a price of 4.0p per share, a 56.9% premium to the closing mid-market price on 11 February 2022;
  • The Agreement is in addition to the Company's existing interest in AZD 1656 as announced on 20 September 2021:
  • SGSC reported the successful completion of the AZD 1656 ARCADIA clinical trial in Covid-19 and SGSC and Conduit are in discussions with multiple pharmaceutical companies about licensing opportunities for AZD 1656 for Covid-19 and potentially for further indications; and
  • The Agreement supports the Company's ambitions to expand its target customer base into the pharmaceutical industry and is in line with its strategy of building a portfolio of early cancer detection tests, companion diagnostics and royalty bearing stakes in significant drug assets.

Consideration for the Agreement (£1.88m) - non cash acquisition

Under the terms of the Agreement, Cizzle paid consideration of £1.88 million to SGS for the Economic Interest. Of the consideration payable, £1.0 million (the "Initial Consideration") was satisfied by the issue of 25,000,000 new ordinary shares in the Company (the "Consideration Shares"), at a price of 4.0 pence per Consideration Share, being a premium of 56.9 per cent. to the Company's closing mid-market price of 2.55 pence on 11 February 2022. The remaining consideration of £880,000 was settled in new ordinary shares in the Company issued at 4.0 pence per share, on 29 September 2022.

Consideration for Put Options (£0.12m)

On 19 December 2022 the Company agreed a put option to sell: (i) its 5% economic interest in the commercialisation of the AZD 1656 asset to treat inflammatory pulmonary and cardiovascular disease (the "Economic Interest"); and (ii) its royalty sharing agreement with St George Street Capital ("SGSC"), the UK-based biomedical charity (the "Royalty Sharing Agreement') to Conduit Pharmaceuticals Limited ("Conduit") for a total expected value of £3.25 million to be satisfied through the issuance of new shares in Conduit (the "Option"). On transfer of the shares to the Company, the shares were worth £2.12 million (refer to note 12). The Economic Interest and Royalty Sharing Agreement were valued at cost, totalling £2,080,000. No profits or revenues were attributable to the assets subject to the Option. The Option is exercisable solely at the discretion of Cizzle and Cizzle has agreed to pay Conduit £120,000 in cash as the premium for the Option, which has a nine-month term. The Company also raised proceeds of £115,586, net of expenses, by way of a subscription for 7,371,557 new ordinary shares in the Company ("Ordinary Shares") at 1.6p per share (the "Issue Price") with existing investors (the "Subscription"), in order to provide funds to be put towards satisfying the Option premium.

This Put Option was paid for in cash and in 2022 was accounted for under prepayments ( see Note 13).

On 26 September 2023 the Company exercised the option to acquire £3,250,000 payable in shares in Conduit Pharmaceuticals Inc, a company that was subsequently listed on NASDAQ during December 2023. The Company were not able to have these shares registered with its custodian until January 2024.

At 1 January 2022, Intangible assets represents the fair value of an investment in a royalty sharing arrangement with St George Street Capital ("SGSC"), a UK-based medical charity. This agreement grants the Company potential future royalty payments from the commercialisation of St George Street's therapeutic asset AZD1656 of up to £5m, plus potentially further payments from the use of a companion diagnostic.

Notes to the financial statements for the year ended 31 December 2024

12. Current asset investment

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Investment 22 1,413 22 1,413
Total investments 22 1,413 22 1,413

Investment – Group and Company

2024 2023
£'000 £'000
Transfer from intangible asset* 1,413 2,124
Measurement loss of level1 investment at (1,391) (711)
year end
Market
value
of
Investment
at
31
December 2023 22 1,413

* During 2023 the Company exercised a put option which meant that the intangible asset was traded for an investment in Conduit Pharmaceuticals Limited ("Conduit") as set out in Note 11 resulting in a gain of £44,000.

The investment noted above represents shares held in Conduit Pharmaceuticals Inc, a NASDAQ-listed company as mentioned in Note 11. The investment is a level 1 investment and has been valued at its market value on 31 December 2024.

13 Inventories

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Raw materials 2 - - -
2 - - -

14 Trade and other receivables

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Amounts due from subsidiaries - - 963 801
Social security and other taxes 7 14 7 6
Corporation tax recoverable 69 95 - -
Prepayments and other receivables 27 27 20 23
103 136 990 830

The fair value of trade and other receivables approximate to the net book values stated above. As of 31 December 2024, trade and other receivables of £Nil (2023: £Nil) were impaired.

Notes to the financial statements for the year ended 31 December 2024

15 Cash and cash equivalents

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Cash on hand and balances with banks 365 144 23 70
365 144 23 70

16 Share capital

Numbers in 000s

New
Ordinary
Shares
Deferred 'A'
shares
Deferred 'A'
shares
Nominal value per share 0.01p 0.01p 0.99p
At 1 January 2024 363,842 12,383,626 225,158
Issued 32,550 - -
At 31 December 2024 396,392 12,383,626 225,158

The above table reflects the full authorised and fully paid shares of the Company at 31 December 2024. There are no shares issued that are partly paid. The following table reconciles the total nominal value of the shares in issue:

Nominal value per share New
Ordinary
shares
0.01p
£000
Deferred
£0.01p
'A' shares
0.01p
£'000
Deferred 'A'
shares
0.99p
£000
Total
£000
At 1 January 2024 37 1,238 2,229 3,504
Issued during the year 3 - - 3
At 31 December 2024 40 1,238 2,229 3,507

During the year ended 31 December 2024, the following shares were issued:

No of shares Issue price
issued per share
000s Pence
11 April 2024 – Subscription (cash) 32,550 2.0p
Total issued 32,550

On 14 May 2021 the Company issued investor warrants to subscribe for 11,000,000 Ordinary Shares at a fixed price of 15p per share valid for three years until 13 May 2024. On 14 May 2021 the Company issued broker and adviser warrants to subscribe for 1,350,000 Ordinary Shares at a fixed price of 10p per share valid for three years until 13 May 2024. 250,000 of these broker warrants are automatically exercisable upon the Company's share price equalling 20p per share. The fair value of these warrants at 31 December 2021 was £36,000 and in 2021 was accounted for as a cost to the Company and a reduction of the share premium account. These warrants expired during the year.

On 11 April 2024 32,550,000 new Ordinary Shares were admitted to the Main Market of the London Stock Exchange due to a share placing that raised gross proceeds of approximately £0.62m (before expenses) and the settlement of £30,000 of professional fees. This is further explained in Note 24.

16 Share capital (continued)

Rights attaching to shares

The rights of each type of share for the Company are as follows:

Rights New Ordinary
0.01p
Deferred 'A'
£0.01p
Deferred 'A'
0.99p
Voting Full voting None None
Dividend Yes None None
Distribution on winding up Yes None Right to a payment of return
of capital after £30m has
been paid in respect of
ordinary shares
Rights of redemption None None None

Substantial shareholdings

At 31 December 2024, shareholders holding at least 3% of new ordinary shares were as follows:

Shareholder Holding of New Ordinary shares
at 31 December 2024
% of New Ordinary Shares held
at 31 December 2024
Hargreaves Lansdowne 43,418,921 11.00%
(Nominees ) Limited
Yorkshire Cancer Research 32,382,330 8.20%
Interactive
Investor
Services
Nominees Limited
31,140,846 7.90%
Hargreaves Lansdown (Nominees)
Limited
28,550,950 7.20%
Hargreaves Lansdown (Nominees)
Limited
25,057,616 6.30%
Barclays
Direct
Investing
Nominees Limited
20,815,095 5.30%
HSDL Nominees Limited 18,880,568 4.80%
Interactive
Investor
Services
Nominees Limited
17,213,120 4.30%
Dawn Coverley * 17,048,137 4.30%
HSBC Global Custody Nominee
(UK) Limited
14,718,227 3.70%
The Bank of New York (Nominees)
Limited
13,083,292 3.30%

*includes holding of 7,055,548 shares held by Dawn Coverley's husband, Dr Justin Ainscough.

Notes to the financial statements for the year ended 31 December 2024

16 Share capital (continued)

Employee share scheme

The Company has an Executive Share Option Scheme. The exercise terms of all granted options as at 31 December 2024 are summarised below:

Date of grant Number of
options
Exercise price
(pence per
share)
Exercise
dates from
2015 300 5.02 2017
2016 800 1.85 2017
2017 500 1.00 2018
2021 19,741,345 10.00 2021 (based on performance)
2023 28,942,498 2.19376p 2024

The number and weighted average exercise price of the options that were exercisable at 31 December 2024 were 48,685,443 and 5.35p respectively. The share based payment charge for the year was £307,000 (2023: £307,000). Included in the share based payment charge for 2024 is £27,000 (2023: £28,000) related to the employee contribution of the national insurance which has been accrued for as the Company has taken on the obligation on the employee's behalf. Movements in the number of share options outstanding and their related weighted average exercise prices are as follows:

Average
exercise price Options
(pence per
share)
number
At 1 January 2024 5.35 48,685,443
Granted during year -
At 31 December 2024 5.35 48,685,443

Share options outstanding at the end of the year have the following expiry dates and exercise prices:

Exercise price Options
Expiry date (pence per 2024
share)
2025 5.02 300
2026 1.85 800
2027 1.00 500
2031 10.00 19,741,345
2033 2.19 28,942,498
48,685,443

The Company determines the fair value of its share option contracts on the grant date, adjusts this to reflect its expectation of the options that will ultimately vest, and then expenses the calculated balance on a straight-line basis through its statement of comprehensive income over the expected vesting period with a corresponding credit to its share option reserve. Subsequent changes to the expectation of number of options that will ultimately vest are dealt with prospectively such that the cumulative amount charged to the statement of comprehensive income is consistent with latest expectations. Subsequent changes in market conditions do not impact the amount charged to the statement of comprehensive income. The Company determines the fair value of its share option contracts using a model based on the Black-Scholes-Merton methodology. In determining the fair value of its share option contracts, the Company made the following assumptions (ranges are provided where values differ across tranches). Expected volatility was determined by reference to historical volatility of the Company's share price.

Grant date Share
Price
Pence
Exercise
Price
Pence
Expected
Option
Life
Years
Expected
Volatility
%
Expected
Dividend
Yield
%
Risk free
Interest
Rate
%
Fair Value
At date of
Grant
Pence
2021 9.38p 1.53p 10 years 68% 0% 0.83% 1.60p
2021 4.40p 10.00p 10 years 32% 0% 0.83% 3.00p
2023 1.95p 2.19p 10 years 58.4% 0% 4.93% 1.32p

Notes to the financial statements for the year ended 31 December 2024

17 Trade and other payables

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Trade payables 13 92 13 41
Social security and other taxes 7 7 7 7
Accruals and other payables 390 87 112 77
410 186 132 125

Accruals and other payables include £227,000 (2023: £Nil) of deferred income relating to royalty payments received that are expected to be accounted for as income in the Statement of Comprehensive Income during 2025.

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Due or due in less than one month 13 68 13 17
Due between one and three months - 17 - 17
Due in more than three months - 7 - 7
13 92 13 41

18 Financial assets and liabilities

The tables below analyse the carrying value of financial assets and financial liabilities in the Group's and Company's statements of financial position. Further information on the classes that make up each category is provided in the notes indicated. The carrying value of each category is considered a reasonable approximation of its fair value. All amounts are due within one year.

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Trade receivables (Note 14) - - - -
Amounts due from subsidiaries (Note 14) - - 963 801
Other receivables (Note 14) 27 27 20 -
Cash and cash equivalents (Note 15) 365 144 23 70
Financial assets at amortised cost 392 171 1,006 871
Financial assets at fair value through profit
or loss (Note12) 22 1,413 22 1,413
Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Trade payables (Note 17) 13 92 13 41
Accruals and other payables (Note 17) 390 87 112 77
Financial liabilities at amortised cost 403 179 125 118

19 Deferred income tax

There is an un-provided deferred tax asset arising on taxable losses of £0.90m (2023: £0.72m). In accordance with accounting standards, the deferred tax asset has not been recognised in the financial statements due to uncertainty over the availability of sufficient future profits against which it could be recovered.

At 31 December 2024 there was no deferred tax liability (2023: £Nil).

Notes to the financial statements for the year ended 31 December 2024

20 Commitments

The Group has no commitments as at 31 December 2024 (2023: £Nil).

21 Related party transactions

Transactions with directors

At 31 December 2024 there were no balances owed to directors other than recent expense claims totalling £3,934 which were paid during January 2024. During 2024 the group paid £4,250 (2023: £10,000) to Dr Justin Ainscough for research and development consultancy work. Dr Ainscough is a shareholder and husband to Professor Dawn Coverley, a director of the Company.

Intercompany transactions

During 2024 and 2023 there have been various intercompany transaction including the recharge of directors salaries to Cizzle Biotechnology Limited that relate to research and development activities. These transactions are reflected in the financial statements of the Company but are eliminated in the Group accounts.

22 Controlling party

The directors consider there to be no ultimate controlling party.

23 Capital management

In managing its capital structure, the Group and Company's objective is to safeguard the Group and Company's ability to continue as a going concern, managing cash flows so that it can continue to provide returns for shareholders.

The Company makes adjustments to its capital structure in the light of changes in economic conditions and the requirements of the Company's businesses. The Board has sought to maintain low levels of borrowing to reflect the development stage of the Company's businesses. Over time as the Company's businesses mature and become profitable the Board is likely to make increased use of borrowing facilities to fund working capital. In order to maintain or adjust the capital structure, the Company may issue new shares or seek additional borrowing facilities. The Company monitors capital on several bases including the debt to equity ratio. This ratio is calculated as debt ÷ equity. Debt is calculated as total borrowings as shown in the consolidated statement of financial position.

Equity comprises all components of equity as shown in the consolidated statement of financial position. The debt-toequity ratio at 31 December 2022 and 31 December 2021 was as follows:

Group Group Company Company
2024 2023 2024 2023
£'000 £'000 £'000 £'000
Total debt - - - -
Total equity 82 1,507 22,706 23,991
Debt-to-equity ratio 0.0% 0.0% 0.0% 0.0%

Notes to the financial statements for the year ended 31 December 2024

24 Reserves

The following reserves describe the nature and purpose of each reserve within equity:

a. Capital reduction reserve

The capital reduction reserve set out in the Statement of Changes in Equity arose in 2014 when the nominal value of each share was reduced from 10p to 1p.

b. Share premium

The amount subscribed for each share in excess of nominal value.

c. Reverse acquisition reserve

The reverse acquisition reserve is explained in Note 3.

d. Share option

The accumulated expense arising during their vesting period of share options granted to directors and employees and warrants granted to third parties.

e. Accumulated losses

All other net losses and gains not recognised elsewhere.

25 Post balance sheet event

The Group announced on 28 April 2025 that its licensing partner Cizzle Bio Inc ("BIO" or "Cizzle Bio") has executed its first contract in the Caribbean as part of the extension to its exclusive licensing and partnership agreement with the Company for the USA and Canada, as announced on 16 December 2024. The non-exclusive Laboratory Services Agreement signed by BIO with Doctors Hospital (Chrissie Tomlinson Memorial Hospital - CTMH) in the Cayman Islands triggers the early royalty payments due to the Company from BIO, totalling US\$500,000 in July and September 2025, as part of the advanced minimum royalty of US\$1 million previously all due on 21 January 2026.

In addition to this further clinical laboratory appointment, BIO is making progress in expanding its network across the USA. Its accreditation and launch plans are now being synchronised to enable a more co-ordinated and comprehensive campaign to roll out the CIZ1B biomarker test to help detect early-stage lung cancer. Cizzle Bio's initial target was to complete CLIA accreditation and secure the first commercial sale of the CIZ1B biomarker test by the end of April 2025. As a consequence of this broader campaign, the launch date has been slightly extended and is now expected to be finalised in the near term.

Key Highlights

  • Cizzle Bio appoints first clinical diagnostics laboratory to offer commercial CIZ1B biomarker testing in the Caribbean triggering early payments totalling US\$250,000 in July 2025 and US\$250,000 in September 2025.
  • The expansion of BIO's laboratory network follows the ongoing and successful collaboration between BIO and the Company to ensure the CIZ1B test for use in helping detect early-stage lung cancer meets the exacting standards as a laboratory developed test for commercial use. It is expected that further sites and commercial launch plans will be announced shortly.

Background

On 21 October 2024 the Company announced an exclusive licensing and partnership agreement with BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA and Canada. The Company has since received payments of US\$400,000 from initial exclusivity fees and advanced royalties as part of guaranteed payments totalling US\$2.4 million over the period ending April 2027. The Company extended that agreement on 16 December 2024 to cover the 14 Sovereign States of the Caribbean and the Cayman Islands ("Caribbean") and the signing of BIO's first contract in the Cayman Islands triggers early payments totalling US\$250,000 in July 2025 and US\$250,000 in September 2025.

BIO's commercial strategy is to work with a number of specialist clinical laboratories to maximise market penetration and make the CIZ1B biomarker test available to as many clinicians and patients as possible. The appointment of accredited facilities to launch the CIZ1B biomarker test involves evaluation of a laboratory's operations, including its testing procedures, quality control, personnel qualifications, and compliance with regulatory requirements. The successful completion of the operational and quality systems programme is required for launching a cost-effective and scalable version of the CIZ1B biomarker that is commercially scalable and can be rolled out as a global solution to help reduce premature cancer deaths and improve survival rates and quality of life for cancer patients.

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